Med Aire 14029Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00822383110820), received between Jul 11, 2022 and Apr 8, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Inflation 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 8, 2026Inflation Problem

  (B)(4) WAS NOTIFIED OF AN INCIDENT 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 REPORTED THAT EVERY THIRD CELL IS NOT INFLATING, THE PUMP ALARMS FOR LOW PRESSURE, AND THE END USER DEVELOPED A PRESSURE SORE THAT REQUIRED TREATMENT AT A WOUND CLINIC. AS PART OF ITS COMPLAINT REVIEW AND EVALUATION PROCESS, (B)(4) WILL ALSO NOTIFY THE MANUFACTURER OF THE PRODUCT ABOUT THIS COMPLAINT.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 24818717 ↗
• InjuryJul 11, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  DRIVE DEVILBISS HEALTHCARE WAS CONTACTED REGARDING A REPORTED INJURY INVOLVING A BARIATRIC LOW AIR LOSS MATTRESS, WHICH IS INTENDED TO BE USED AS ONE COMPONENT OF A COMPREHENSIVE, MULTI-DISCIPLINARY PRESSURE INJURY MANAGEMENT PROGRAM. THE END USER REPORTED DEVELOPING A PRESSURE SORE WHILE USING THE DEVICE. DRIVE DID NOT RECEIVE ANY INFORMATION REGARDING THE PATIENT'S OVERALL PRESSURE INJURY MANAGEMENT PROGRAM. DRIVE HAS ATTEMPTED TO CONTACT THE END USER TO GATHER ADDITIONAL INFORMATION AND RETRIEVE THE PRODUCT FOR EVALUATION, BUT THERE HAS BEEN NO RESPONSE. DRIVE WILL FILE AN UPDATE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Ulcer

  MAUDE report 14977335 ↗