Reported Reactions

Devices › Ventilator, non-continuous (respirator)

Device brand name · Ventilator non-continuous respirator

Philips CPAP Device: medical device reports filed with FDA

12,779 reports name it, 2022–2026. Manufacturer given most often on reports: Respironics. Product code BZD.

12,779
device reports naming the brand
0% of all MAUDE reports · about 2,950 a year
58
reports, 12 months to August 2026
1,801 in the 12 months before
33.9%
classified as malfunction
80.7% across the product code
5.5%
classified as death, as reported
698 reports · not verified by FDA

12,779 medical device reports received by FDA name the brand "Philips CPAP Device" (ventilator non-continuous respirator); the manufacturer given most often on reports is Respironics; received from March 2022 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

58 reports arrived in the 12 months to August 2026, down 97% from 1,801 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are injury (60.7%), malfunction (33.9%) and death (5.5%); across all ventilator, non-continuous (respirator) reports (product code BZD) death is recorded in 1.5% and malfunction in 80.7%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are degraded (98.4%), contamination (0.3%) and material integrity problem (0.3%). The patient problems coded most often are headache, asthma and cancer. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Reports by month, five years

07421,483Sep 2021: 0Oct 2021: 0Nov 2021: 0Dec 2021: 02022Jan 2022: 0Feb 2022: 0Mar 2022: 1Apr 2022: 0May 2022: 0Jun 2022: 1Jul 2022: 11Aug 2022: 26Sep 2022: 39Oct 2022: 418Nov 2022: 1,320Dec 2022: 1202023Jan 2023: 90Feb 2023: 16Mar 2023: 9Apr 2023: 19May 2023: 72Jun 2023: 38Jul 2023: 80Aug 2023: 317Sep 2023: 701Oct 2023: 94Nov 2023: 342Dec 2023: 2712024Jan 2024: 414Feb 2024: 534Mar 2024: 566Apr 2024: 1,483May 2024: 1,400Jun 2024: 881Jul 2024: 946Aug 2024: 711Sep 2024: 117Oct 2024: 549Nov 2024: 493Dec 2024: 1592025Jan 2025: 372Feb 2025: 18Mar 2025: 21Apr 2025: 16May 2025: 20Jun 2025: 16Jul 2025: 12Aug 2025: 8Sep 2025: 7Oct 2025: 7Nov 2025: 9Dec 2025: 32026Jan 2026: 7Feb 2026: 8Mar 2026: 8Apr 2026: 2May 2026: 2Jun 2026: 2Jul 2026: 2Aug 2026: 1

Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

By year received

04,1278,2532022: 1,93620222023: 2,04920232024: 8,25320242025: 50920252026: 322026

Event type and report source

Event type, as classified on the report

Death5.5%698
Injury60.7%7,754
Malfunction33.9%4,327
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%12,779
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

Grey bar: all 303,240 reports carrying product code BZD. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)ReportsShareShare across product code
Degraded12,57698.4%95.4%
Contamination440.3%4.4%
Material integrity problema problem with the device material340.3%0.2%
Insufficient device problem information170.1%0.2%
Device emits odor120.1%0.2%
Overheating of device110.1%0.7%
Smoking100.1%0.1%
Chemical problem50%0%
Crackthe device cracked40%0%
Device contamination with chemical or other material40%0.1%
Excessive heating40%0.1%
Material split, cut or torn40%0%
Breakthe device broke30%0%
Corrodedthe device corroded30%0.8%
Noise, audible30%0.1%
Sparking30%0%
Unraveled material30%0%
Contamination /decontamination problem20%0.1%
Failure to power up20%0.1%
Fire20%0.1%

FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.

Patient problems coded

Patient problem (FDA code)ReportsShare
Headachehead pain3,06124%
Asthmaasthma2,76821.7%
Cancer2,67520.9%
Dizzinesslight-headedness or unsteadiness2,62820.6%
Eye irritationeye irritation1,34610.5%
Skin inflammation/ irritation1,1459%
Inflammationinflammation1,0338.1%
Respiratory tract infectiona respiratory infection1,0228%
Nauseafeeling sick8846.9%
Dyspneashortness of breath8646.8%
Vomitingbeing sick8166.4%
Hypersensitivity/allergic reaction7756.1%
Chronic obstructive pulmonary disease (COPD)5003.9%
Appropriate clinical signs, symptoms and conditions term/code not available4753.7%
Coughcough4683.7%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

MeasurePhilips CPAP DeviceProduct code BZDAll MAUDE reports
Reports12,779303,24026,136,888
Share of that pool—4.2%0%
Classified as death, per 1,000 reports55159
Classified as injury60.7%17.7%36.2%
Classified as malfunction33.9%80.7%62.3%
Filed by the manufacturer100%99%94.9%

Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Other brands with product code BZD

BrandReportsLatest 12 monthsClassified as death
DreamStation Auto CPAP146,78027,7410.9%
REMstar Auto A-Flex19,6567,0831%
DreamStation Auto BiPAP15,3168711.8%
REMstar Pro C-Flex+14,6434,6891.2%
DreamStation CPAP13,8953362.5%
DreamStation CPAP Pro10,7896740.8%
REMstar AutoA-Flex8,6591,7321.1%
REMstar Auto5,0891,4240.9%
BiPAP Auto BiFlex4,4871,3271.4%
DreamStation4,2101,7031.6%
REMstar Plus C-Flex3,6821,5820.8%
Dreamstation Auto3,150380.3%
DreamStation BiPAP Pro3,0491081.9%
REMstar Plus2,5814991.9%
Philips CPAP2,470114.3%

Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."

Questions about Philips CPAP Device reports

How many FDA reports name Philips CPAP Device?

12,779 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 58 in the latest 12 months.

What kinds of events are reported?

injury (60.7%), malfunction (33.9%) and death (5.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

degraded (98.4%), contamination (0.3%), material integrity problem (0.3%), insufficient device problem information (0.1%) and device emits odor (0.1%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Philips CPAP Device was at fault?

No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."

How do I report a problem with a medical device?

Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.

Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.