BiPAP A40 DEX3000S13Recalls & reported problems
Respironics, Inc. · BiPAP A40 EFL, DE · Class 2
All models of BiPAP A40 (37)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00606959055377), received between Nov 27, 2023 and Nov 27, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Output Problem” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Recalls naming this device
- Mar 26, 2024Class IOpen, Classified
Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death in the most vulnerable patients.
Z-1813-2024 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- Output Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 27, 2023Output Problem; Output Problem
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A HIGH O2 CONDITION OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18209989 ↗
Other Ventilator, continuous, minimal ventilatory support, facility use devices
- Philips Respironics V60Respironics California, Inc. · Ventilator, Continuous, Minimal Ventilatory Support,Facility Use3 recalls30 deaths13,525 reports
- PHILIPS 1076716Respironics California, Inc. · Ventilator, continuous, minimal ventilatory support, facility use2 recalls1 death2,946 reports
- PHILIPS 1076709Respironics California, Inc. · Ventilator, continuous, minimal ventilatory support, facility use8 deaths2,174 reports
- PHILIPS 1053614Respironics California, Inc. · Ventilator, continuous, minimal ventilatory support, facility use2 recalls4 deaths1,203 reports
- BiPAP A40 EEX3100S19Respironics, Inc. · Ventilator, continuous, minimal ventilatory support, facility use2 recalls422 reports
- BiPAP A40 DEX3100S13Respironics, Inc. · Ventilator, continuous, minimal ventilatory support, facility use2 recalls164 reports
- BiPAP A40 ITX3100S21Respironics, Inc. · Ventilator, continuous, minimal ventilatory support, facility use2 recalls163 reports
- PHILIPS 1053613Respironics California, Inc. · Ventilator, continuous, minimal ventilatory support, facility use2 recalls1 death161 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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