Med Aire 14030Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00822383111605), received between Apr 6, 2022 and Jan 6, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Decreased Pump Speed” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 6, 2023Inflation Problem; Inflation Problem

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A PRESSURE PREVENTION MATTRESS VIA MEDWATCH REPORT. THE INITIAL REPORTER STATED THAT "HIS PATIENT SUFFERED BRUISING ON HER HEAD FROM FALLING OUT OF THE MATTRESS," REPORTEDLY BECAUSE THE "PUMP WAS NOT WORKING, CAUSING THE MATTRESS TO DEFLATE," "WHICH THEN CAUSED THE PATIENT TO FALL ON THE FLOOR." THE PATIENT WAS REPORTEDLY ADMITTED TO THE HOSPITAL AND HAS BEEN RECEIVING THERAPY POST-HOSPITALIZATION. DRIVE OBTAINED THE UNIT FOR EVALUATION, DURING WHICH IT WAS DETERMINED THAT THE PUMP OPERATES AS INTENDED AND FILLS BLADDER TO FULL HEIGHT. DURING EVALUATION, DRIVE NOTED THAT THE UNIT'S EMERGENCY CORD, USED TO DEFLATE THE UNIT IMMEDIATELY IF CPR IS NECESSARY, WAS DISCONNECTED WHEN RECEIVED. IF THE EMERGENCY CORD WAS DISCONNECTED DURING USE, IT WOULD RESULT IN THE COMPLETE DEFLATION OF THE BLADDER.

  Patient problems: Bruise/Contusion; Head Injury

  MAUDE report 16112164 ↗
• InjuryJul 13, 2022Decreased Pump Speed; Decreased Pump Speed

  DRIVE DEVILBISS HEALTHCARE WAS CONTACTED BY A DISTRIBUTOR REGARDING A REPORTED INJURY INVOLVING A BARIATRIC ALTERNATING PRESSURE AND LOW AIR LOSS MATTRESS SYSTEM, WHICH IS INTENDED TO BE USED AS ONE COMPONENT OF A COMPREHENSIVE, MULTI-DISCIPLINARY PRESSURE INJURY MANAGEMENT PROGRAM. THE END USER STATED THAT THE SYSTEM'S PUMP WAS DEFECTIVE BECAUSE IT "WON'T ALLOW HIM TO LOCK, CHANGE WEIGHT OR INFLATE." HE REPORTED HAVING DEVELOPED PRESSURE ULCERS AS A RESULT AND RECEIVING MEDICAL TREATMENT FOR THEM. DRIVE DID NOT RECEIVE ANY INFORMATION REGARDING THE PATIENT'S OVERALL PRESSURE INJURY MANAGEMENT PROGRAM. DRIVE IS CURRENTLY INVESTIGATING THE INCIDENT, INCLUDING ATTEMPTING TO RETRIEVE THE PRODUCT TO EVALUATE IT. DRIVE WILL UPDATE THIS FILING IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Ulcer

  MAUDE report 15001780 ↗
• InjuryApr 6, 2022No Pressure; No Pressure

  (B)(6) HEALTHCARE WAS CONTACTED ON (B)(6) 2022 REGARDING A REPORTED INJURY INVOLVING A BARIATRIC LOW AIR LOSS MATTRESS, WHICH ARE INTENDED TO BE USED AS ONE COMPONENT OF A COMPREHENSIVE, MULTI-DISCIPLINARY PRESSURE INJURY MANAGEMENT PROGRAM. THE PATIENT'S OCCUPATIONAL THERAPIST REPORTS THAT THE PATIENT, WHO IS BED BOUND, RECEIVED THE MATTRESS IN (B)(6) 2021 AND HAD PROBLEMS WITH IT FROM THE BEGINNING, BUT WAS UNABLE TO GET THE SERVICE PROVIDER TO COME LOOK AT IT DURING THE PANDEMIC, AND NOW THE SERVICE PROVIDER WILL NOT RETURN CALLS. THE THERAPIST REPORTED THAT "THE MATTRESS WILL NOT ALTERNATE," AND THAT THE PATIENT HAS DEVELOPED 2 PRESSURE SORES DUE TO THE MATTRESS NOT FUNCTIONING PROPERLY. (B)(6) HAS YET TO RECEIVE ANY INFORMATION REGARDING THE PATIENT'S OVERALL PRESSURE INJURY MANAGEMENT PROGRAM. (B)(6) IS WORKING TO HAVE THE PRODUCT RETURNED FOR EVALUATION, AND WILL CONTINUE TO INVESTIGATE THE INCIDENT.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 14021572 ↗