PerforMax PerforMax Mask with EE, Single Patient Use, Large, USARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00606959004085), received between Dec 22, 2016 and Dec 22, 2016 — classified as 1 death.

The most frequently reported specific device problem is “Mechanical Problem” (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.

• DeathDec 22, 2016Mechanical Problem; Mechanical Problem

  A VOLUNTARY MEDWATCH (B)(4) WAS RECEIVED BY THE MANUFACTURER ON 11/28/2016, INDICATING A PATIENT DEATH HAD OCCURRED IN A FACILITY ON (B)(6) 2016. THE PATIENT HAD A SIGNIFICANT MEDICAL HISTORY OF DEMENTIA, DIASTOLIC CONGESTIVE HEART FAILURE, AND ATRIAL FIBRILLATION, AND HAD BEEN ADMITTED TO THE INTENSIVE CARE UNIT (ICU) WITH HYPERCAPNIC RESPIRATORY FAILURE. THE REPORT INDICATED THAT THE (B)(6) FEMALE WAS PLACED ON A MEDICAL-SURGICAL FLOOR AFTER BEING DISCHARGED FROM ICU, AND WAS USING A BI-LEVEL POSITIVE AIRWAY PRESSURE (BIPAP), A PERFORMAX TOTAL FACE MASK, AND A BIPAP DISPOSABLE PATIENT CIRCUIT. THE PATIENT WAS SUBSEQUENTLY FOUND IN CARDIAC ARREST, WITH THE BIPAP PATIENT CIRCUIT DETACHED FROM THE MASK. RESUSCITATION WAS UNSUCCESSFUL. THE EXACT CAUSE OF DEATH REMAINS UNKNOWN BECAUSE THE FAMILY DECLINED AN AUTOPSY. THE RISK MANAGER FOR THE FACILITY CONFIRMED THE BIPAP SERIAL NUMBER AND CATALOG NUMBER TO THE MANUFACTURER AFTER THE INITIAL REPORT WAS FILED, AND STATED THE DEVICE DID NOT ANNUNCIATE AN ALARM FOR PATIENT DISCONNECT BECAUSE IT WAS NOT THE TYPE OF DEVICE THAT HAD ALARMS BUILT IN. THE PERFORMAX FULL FACE MASK AND BIPAP PATIENT CIRCUIT WERE DISCARDED BY THE FACILITY. THE BIPA

  Patient problems: Death

  MAUDE report 6198809 ↗