PerforMax PerforMax Mask with EE, Single Patient Use, Small, USARecalls & reported problems
Respironics, Inc. · PerforMax Mask with Entrainment Elbow, Single Patient Use, Small, USA · 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 00606959004078), received between Jan 7, 2022 and Jan 7, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
Patient problems
- Bradycardia1
- 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.
InjuryJan 7, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
THE MANUFACTURER BECAME AWARE OF AN EVENT ALLEGING THAT A PERFORMAMAX FULL FACE MASK'S ELBOW DISCONNECTED FROM THE MASK HUB WHILE IN USE WITH A V60 VENTILATOR ON A COVID-19 PATIENT. THE WAS NO ALLEGATION OF MALFUNCTION AGAINST THE VENTILATOR. THE USER DESATURATED, BECAME HYPOXIC AND BRADYCARDIC, AND MEDICAL INTERVENTION WAS REQUIRED. THE MASK WILL NOT BE RETURNED FOR EVALUATION DUE TO COVID 19 CONTAMINATION. EVALUATION OF SAME MASK AND LOT NUMBER WILL BE PERFORMED FOR INVESTIGATION IF AVAILABLE. A FOLLOW UP FINAL WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED.
Patient problems: Bradycardia; Low Oxygen Saturation
MAUDE report 13191447 ↗
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- DreamStation DreamStation Auto CPAP w/Humid w/Heated Tube, USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)30 deaths3,981 reports
- DreamStation DreamStation Auto CPAP w/Humidifier, w/Cell, USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)86 deaths3,516 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
- 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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