Med Aire 14060Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00822383118277), received between Mar 13, 2024 and Mar 13, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Pumping 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.

• InjuryMar 13, 2024Pumping Problem; Pumping Problem

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF A COMPLAINT INVOLVING A PRESSURE PREVENTION MATTRESS, WHICH IS INTENDED TO BE USED AS ONE COMPONENT OF A COMPREHENSIVE, MULTI-DISCIPLINARY PRESSURE INJURY MANAGEMENT PROGRAM. THE END USER'S HOME HEALTH NURSE REPORTED THAT THE PUMP TO THE MATTRESS WAS ALARMING SEVERAL TIMES A DAY FOR LOW PRESSURE. SHE REPORTED THAT THE PROVIDER OF THE MATTRESS WAS NOTIFIED AND MADE MULTIPLE SERVICE CALLS. THE END USER DEVELOPED A PRESSURE SORE AND WAS ADMITTED TO THE HOSPITAL FOR DEBRIDEMENT. THE END USER HAS SINCE BEEN RELEASED FROM THE HOSPITAL. IT IS UNCLEAR WHEN THE PRESSURE SORE BEGAN TO DEVELOP, OR WHAT OTHER ELEMENTS OF THE PRESSURE INJURY MANAGEMENT PROGRAM WERE IMPLEMENTED. THE MATTRESS AND PUMP WERE DISCARDED AND CANNOT BE EVALUATED. DRIVE DEVILBISS IS INVESTIGATING THE INCIDENT, AND AN UPDATE WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 18894661 ↗