CARDINAL HEALTH AN1428752BRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887488334745), received between Sep 1, 2016 and Sep 1, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (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.

• MalfunctionSep 1, 2016Material Deformation

  BASED ON THE CUSTOMERS REPORT THE ISSUE WITH THE MASK WAS THAT THEY HAD A VERY LARGE GENTLEMAN WITH A BEARD WHO DESATURATED QUICKLY AFTER INDUCTION OF GENERAL ANESTHESIA. DURING VENTILATION THEY WERE HAVING DIFFICULTY WHICH WAS PARTLY DUE TO THE MASK BEING "FLAT". THEY WERE ABLE TO VENTILATE AND GET HIS SPO2 UP AGAIN BEFORE INTUBATING HIM. THEY OBTAINED A REPLACEMENT MASK DURING THE EPISODE. UPON THERE INSPECTION OF THE MASK AFTER THE INCIDENT, THEY FOUND THE PARTS OF THE INFLATION VALVE INSIDE THE INFLATABLE RIM OF THE MASK. THE RESIDENT ON THE CASE STATED THAT SHE HAD INFLATED THE MASK DURING THE MACHINE CHECK; IN FACT, SHE STATES THAT THIS IS STANDARD FOR HER SINCE THE MASKS OFTEN SEEM TO BE "FLAT" WHEN THEY COME OUT OF THE PACKAGE. I CAN NOT BE SURE IF THE VALVE WAS DAMAGED PRIOR TO THE CASE OR IF IT COULD HAVE BEEN DAMAGED BY SOMEONE INSERTING A SYRINGE INTO THE VALVE TO INFLATE IT.

  Patient problems: Hypoxia

  MAUDE report 5923233 ↗