Devices › Nebulizer, medicinal, non-ventilatory (atomizer)
Device brand name · Atomizer
Ez Breathe Atomizer: medical device reports filed with FDA
189 reports name it, 2013–2016. Manufacturer given most often on reports: Health & Life Suzhou. Product code CCQ.
- 189
- device reports naming the brand
- 0% of all MAUDE reports · about 14 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 55%
- classified as malfunction
- 68.2% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
189 medical device reports received by FDA name the brand "Ez Breathe Atomizer" (atomizer); the manufacturer given most often on reports is Health & Life Suzhou; received from February 2013 to February 2016. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
0 reports arrived in the 12 months to August 2026, and none 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 (55%), injury (10.1%) and other (0.5%); across all nebulizer, medicinal, non-ventilatory (atomizer) reports (product code CCQ) death is recorded in 0.3% and malfunction in 68.2%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are detachment of device component (43.4%), device operates differently than expected (36%) and loss of or failure to bond (28.6%). The patient problems coded most often are choking, asthma and foreign body in patient. 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
No report naming Ez Breathe Atomizer was received in the five years to August 2026; the latest was received in February 2016.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 623 reports carrying product code CCQ. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Detachment of device component | 82 | 43.4% | 22.6% |
| Device operates differently than expectedthe device behaved unexpectedly | 68 | 36% | 16.9% |
| Loss of or failure to bond | 54 | 28.6% | 10% |
| Failure to fire | 49 | 25.9% | 9.5% |
| Component falling | 33 | 17.5% | 7.4% |
| Nonstandard device | 15 | 7.9% | 3.4% |
| Breakthe device broke | 6 | 3.2% | 7.7% |
| Device inoperablethe device could not be used | 5 | 2.6% | 2.9% |
| Inadequate instructions for non-healthcare professional | 4 | 2.1% | 1% |
| Complete blockage | 3 | 1.6% | 3% |
| Unintended ejection | 3 | 1.6% | 0.6% |
| Insufficient flow or under infusion | 2 | 1.1% | 1.4% |
| Loose or intermittent connection | 2 | 1.1% | 2.1% |
| No device output | 2 | 1.1% | 1.9% |
| Battery problema problem with the battery | 1 | 0.5% | 0% |
| Device difficult to maintain | 1 | 0.5% | 0% |
| Failure to convert to back-up | 1 | 0.5% | 0.3% |
| Failure to deliverthe device did not deliver the dose or item | 1 | 0.5% | 6.1% |
| Infusion or flow problema problem with flow or infusion | 1 | 0.5% | 0.2% |
| Material integrity problema problem with the device material | 1 | 0.5% | 0.3% |
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) | Reports | Share |
|---|---|---|
| Chokingchoking | 62 | 32.8% |
| Asthmaasthma | 59 | 31.2% |
| Foreign body in patientpart of a device left in the patient | 7 | 3.7% |
| Respiratory distressdifficulty breathing | 4 | 2.1% |
| Dyspneashortness of breath | 3 | 1.6% |
| Underdoseless than the intended dose | 3 | 1.6% |
| Bronchospasmtightening of the airways | 2 | 1.1% |
| Complaint, ill-defined | 2 | 1.1% |
| Irritationirritation | 2 | 1.1% |
| Arthritis | 1 | 0.5% |
| Aspiration/inhalation | 1 | 0.5% |
| Device embedded in tissue or plaque | 1 | 0.5% |
| Sore throat | 1 | 0.5% |
| Vomitingbeing sick | 1 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Ez Breathe Atomizer | Product code CCQ | All MAUDE reports |
|---|---|---|---|
| Reports | 189 | 623 | 26,136,888 |
| Share of that pool | — | 30.3% | 0% |
| Classified as death, per 1,000 reports | 0 | 3 | 9 |
| Classified as injury | 10.1% | 8.3% | 36.2% |
| Classified as malfunction | 55% | 68.2% | 62.3% |
| Filed by the manufacturer | 36.5% | 62.6% | 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 CCQ
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Hudson Nebulizer Adaptor 033 Sterile Japanese | 190 | 0 | 0% |
| Hudson Micro Mist Nebulizer W/Elong | 264 | 0 | 0% |
| Salter Labs | 168 | 15 | 0.6% |
| AirLife | 155 | 37 | 2.6% |
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 Ez Breathe Atomizer reports
How many FDA reports name Ez Breathe Atomizer?
189 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
malfunction (55%), injury (10.1%) and other (0.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
detachment of device component (43.4%), device operates differently than expected (36%), loss of or failure to bond (28.6%), failure to fire (25.9%) and component falling (17.5%). These are FDA's device problem codes as entered on the report.
Who files these reports?
distributor reports (61.4%), manufacturer reports (36.5%) and voluntary reports (2.1%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Ez Breathe Atomizer 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.