PerforMax Performax Mask with EE and SE, MPU, Leak 2, Small, USARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00606959000759), received between Mar 18, 2021 and Mar 18, 2021 — 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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 18, 2021Disconnection; Mechanical Problem; Unintended Movement; Disconnection; Mechanical Problem; Unintended Movement

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THAT WHILE ON A BILEVEL POSITIVE AIRWAY PRESSURE (BIPAP) DEVICE, A PATIENT BECAME CONFUSED AND REMOVED THE PERFORMAX MASK. THE PATIENT SUBSEQUENTLY REQUIRED INTUBATION DUE TO OXYGEN DESATURATION. THE MANUFACTURER HAS MADE NUMEROUS ATTEMPTS TO CONTACT THE REPORTING FACILITY TO GATHER ADDITIONAL INFORMATION AND TO REQUEST RETURN OF THE MASK FOR INVESTIGATION. NO FURTHER INFORMATION HAS BEEN PROVIDED, AND NO PRODUCT HAS BEEN RETURNED. THE PERFORMATRAK FULL FACE MASK IS INTENDED TO PROVIDE AN INTERFACE FOR APPLICATION OF CPAP OR BI-LEVEL THERAPY TO PATIENTS. THE MASK IS FOR SINGLE USE IN THE HOSPITAL/INSTITUTIONAL ENVIRONMENT. THE MASK IS TO BE USED ON PATIENTS (>66LBS/30KG) FOR WHOM CPAP OR BI-LEVEL THERAPY HAS BEEN PRESCRIBED. LABELING WARNS THE USER "THIS MASK IS NOT SUITABLE FOR PROVIDING LIFE SUPPORT VENTILATION", AND THAT "THIS MASK SHOULD NOT BE USED ON PATIENTS WHO ARE UNCOOPERATIVE, OBTUNDED, UNRESPONSIVE, OR UNABLE TO REMOVE THE MASK." AS NO FURTHER INFORMATION WAS PROVIDED, AND NO PRODUCT RETURNED, THE MANUFACTURER IS UNABLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED EVENT. THE MANUFACTURER CONCLUDES NO FURTHER ACTION IS NECESS

  Patient problems: Low Oxygen Saturation

  MAUDE report 11517382 ↗