AF531 AF531 Mask EE, Leak 1 with 4 PT Headgear, Medium, SURecalls & reported problems
Respironics, Inc. · AF531 Mask with Entrainment Elbow, Leak 1, 4 Point Headgear, Single Use, Medium · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00606959007406), received between Aug 10, 2023 and Aug 10, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Disconnection” (1 report).
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.
Most reported problems
Device problems
- Disconnection1
Patient problems
- Low Oxygen Saturation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 10, 2023Disconnection; Disconnection
THE MANUFACTURER RECEIVED INFORMATION THAT A CUSTOMER REPORTED AN EVENT TO THE NMPA OCCURRING ON (B)(6) 2023. THE CUSTOMER STATED THAT WHEN A PATIENT WAS USING A V60 NON-INVASIVE VENTILATOR, THE CONNECTION OF THE AF531 EE LEAK1 MASK FELL OFF, AND THE MASK COULD NOT BE USED NORMALLY. THIS LED TO A DECREASE IN BLOOD OXYGEN AND DELAYED TREATMENT OF THE PATIENT. THE CUSTOMER ALSO REPORTS THAT THE CLINICAL PROCEDURE/TREATMENT WAS STOPPED AND RE-STARTED, AND THE MASK WAS REPLACED. NO OTHER CLINICAL INFORMATION OR MEDICAL INTERVENTION WAS REPORTED. (REFERENCE NMPA ADVERSE EVENT (B)(4).) 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: Low Oxygen Saturation
MAUDE report 17503903 ↗
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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
- 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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