Device manufacturer, as written on reports

Resmed: medical device reports filed with FDA

18,369 reports name it as the manufacturer of the device involved, 2001–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "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."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

18,369
reports naming it as manufacturer: 0.1% of all MAUDE reports; 1,045
reports, 12 months to August 2026: 883 in the 12 months before; 95.2%
classified as malfunction: 62.3% across all reports; 1.2%
classified as death, as reported: 0.9% across all reports

18,369 medical device reports received by FDA give Resmed as the manufacturer of the device involved, 0.1% of the MAUDE database, from March 2001 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

1,045 reports arrived in the 12 months to August 2026, up 18% from 883 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 malfunction (95.2%), injury (3.2%) and death (1.2%). Manufacturers are required to report events they learn of, so a large manufacturer with many products in use files many reports. 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."

Brands named most often

Brand	Device type	Reports	Latest 12 months	Classified as death
Astral 150 - AMER	Ventilator, continuous, facility use	3,904	272	0.8%
Astral 150 Dbl Kit Fra	Ventilator, continuous, facility use	1,877	12	1.1%
Astral 150 - Fukuda	Ventilator, continuous, facility use	1,789	84	0.2%
Astral 150 - DEU	Continuous, ventilator, home use	1,484	76	0.1%
Astral 100 - AMER	Ventilator, continuous, facility use	1,080	92	1%
Astral 150 -EUR4	Ventilator, continuous, facility use	769	92	0.4%
Astral 150 - Apac2	Ventilator, continuous, facility use	605	18	0%
Astral 100 - APAC2	Ventilator, continuous, facility use	593	38	0.3%
Astral Battery Pack	Ventilator, continuous, facility use	488	0	0%
Astral 100 - Eur1	Ventilator, continuous, facility use	481	8	0%
Astral 150 - Eur2	Ventilator, continuous, facility use	397	22	0.5%
Astral 100 Deu	Continuous, ventilator, home use	365	6	0%
Astral 150 Dbl Kit - Eur4	Ventilator, continuous, facility use	256	2	0%
Astral 100 Sc - Deu	Continuous, ventilator, home use	244	0	0%
Astral 150 - APAC1	Ventilator, continuous, facility use	209	16	0%
Astral 100 - EUR4	Ventilator, continuous, facility use	203	6	2%
Astral 150 - EUR1	Ventilator, continuous, facility use	198	18	0%
Astral 150 - Apac	Ventilator, continuous, facility use	197	6	0%
Astral 100 - Apac	Ventilator, continuous, facility use	174	2	0%
Astral 150 - EUR3	Ventilator, continuous, facility use	170	10	0%

Brands with a page on this site, 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."

Device types

Product code	Device type	Reports	Share
CBK	Ventilator, continuous, facility use	10,609	57.8%
NOU	Continuous, ventilator, home use	6,630	36.1%
BZD	Ventilator, non-continuous (respirator)	1,048	5.7%
MNT	Sv70 ventilator	79	0.4%
CAT	Cannula, nasal, oxygen	68	0.4%
MNS	Ventilator, continuous, non-life-supporting	51	0.3%
BYG	Mask, oxygen	10	0.1%
LRJ	Disinfectant, medical devices	10	0.1%
BTT	Humidifier, respiratory gas, (direct patient interface)	8	0%
CAW	Generator, oxygen, portable	7	0%

Reports by month, five years

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

Event type

Death1.2%215

Injury3.2%596

Malfunction95.2%17,480

Other0.3%61

Not given0.1%17

Grey bar: all 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.

Questions about Resmed reports

How many FDA device reports name Resmed as manufacturer?

18,369 reports through August 2026, 1,045 of them in the latest 12 months.

Which of its brands appear most often?

Astral 150 - AMER (3,904), Astral 150 Dbl Kit Fra (1,877), Astral 150 - Fukuda (1,789), Astral 150 - DEU (1,484) and Astral 100 - AMER (1,080).

Which device types does it report on?

ventilator, continuous, facility use (57.8%), continuous, ventilator, home use (36.1%), ventilator, non-continuous (respirator) (5.7%) and sv70 ventilator (0.4%).

Does a high count say something about the manufacturer?

Not by itself. Manufacturers must file a report for every event they become aware of, so report volume follows the number 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."

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. Manufacturer names are pooled after company suffixes (Inc., LLC, GmbH and similar) are dropped; names that read as a person rather than an organisation are never published. 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.