Med Aire 14027Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00822383221618), received between Jul 12, 2017 and Sep 22, 2026 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Inflation Problem” (2 reports).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjurySep 22, 2026Mechanical Problem

  Patient problems: Ulcer

  MAUDE report 50855088 ↗
• InjuryJul 23, 2025Deflation Problem; Deflation Problem

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED BY AN END USER 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 THE TOP CELLS OF THE MATTRESS ARE LEAKING. THE END USER HAS BEEN USING THE MATTRESS FOR THREE MONTHS WHILE THE BED WAS LEAKING. HE HAS REPORTEDLY DEVELOPED A BED SORE ON HIS BACK FROM LAYING AGAINST THE HARD BED FRAME. THE END USER'S HOME NURSE HAS BEEN TREATING THE WOUND. AS PART OF ITS COMPLAINT REVIEW AND EVALUATION PROCESS, DRIVE DEVILBISS HEALTHCARE WILL ALSO NOTIFY THE MANUFACTURER OF THE PRODUCT ABOUT THIS COMPLAINT.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 22577797 ↗
• InjuryApr 12, 2023Inflation Problem; Inflation Problem

  DRIVE DEVILBISS HEALTHCARE 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'S DAUGHTER STATED THAT "THE UNIT HAD A DEFLATED BLADDER, AND THE END USER IS STARTING TO DEVELOP BED SORES." DRIVE DID NOT RECEIVE ANY INFORMATION REGARDING THE PATIENT'S OVERALL PRESSURE INJURY MANAGEMENT PROGRAM. THE END USER DISCARDED THE UNIT AND IS UNABLE TO RETURN TO DRIVE FOR AN EVALUATION. DRIVE IS CURRENTLY INVESTIGATING THE INCIDENT AND WILL FILE AN UPDATE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 16724010 ↗
• MalfunctionFeb 3, 2023Inflation Problem; Inflation Problem

  DRIVE DEVILBISS HEALTHCARE 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 OF THE MATTRESS STATED "THE MATTRESS DEFLATES IN 5 MINS AFTER INFLATING," BUT HE "CANNOT FIND A LEAK IN THE MATTRESS." HE REPORTED THAT HE IS "STARTING TO DEVELOP BED SORES." DRIVE DID NOT RECEIVE ANY INFORMATION REGARDING THE PATIENT'S OVERALL PRESSURE INJURY MANAGEMENT PROGRAM. THE END USER REQUESTED A REPLACEMENT AND DID NOT RETURN THE PRODUCT TO DRIVE.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 16294317 ↗
• InjuryJul 11, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  DRIVE DEVILBISS HEALTHCARE WAS CONTACTED REGARDING A REPORTED INJURY INVOLVING A ALTERNATING PRESSURE MATTRESS LOW AIR LOSS SYSTEM, WHICH IS INTENDED TO BE USED AS ONE COMPONENT OF A COMPREHENSIVE, MULTI-DISCIPLINARY PRESSURE INJURY MANAGEMENT PROGRAM. THE END USER REPORTED HAVING DEVELOPED A PRESSURE WOUND ON HER BOTTOM PRIOR TO COMMENCING USE OF THE DEVICE. AFTER APPROXIMATELY EIGHT MONTHS OF USING THE DEVICE, HER CARETAKERS BEGAN TO NOTICE THE DEVELOPMENT OF ADDITIONAL PRESSURE WOUNDS, AND SHE WAS TAKEN TO THE HOSPITAL. DRIVE DID NOT RECEIVE ANY INFORMATION REGARDING THE PATIENT'S OVERALL PRESSURE INJURY MANAGEMENT PROGRAM. DRIVE PROVIDED A REPLACEMENT MODEL TO THE END USER, AND IS CURRENTLY INVESTIGATING THE INCIDENT, INCLUDING ATTEMPTING TO RETRIEVE THE PRODUCT TO EVALUATE IT.

  Patient problems: Ulcer

  MAUDE report 14978480 ↗
• InjuryApr 13, 2022Dent in Material; Dent in Material

  ON (B)(6) 2022, DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT REGARDING AN 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 REPORTED THAT THE MATTRESS SYSTEM, WHICH IS USED BY HER SON, WHO IS PARALYZED, WAS SINKING IN THE CENTER CELLS. A REPLACEMENT PUMP WAS PROVIDED, BUT IT DID NOT RESOLVE THE ISSUE. SHE STATED THAT HER SON "IS NOW DEVELOPING A LOT OF BED SORES DUE TO THIS." DRIVE HAS YET TO RECEIVE ANY INFORMATION REGARDING THE PATIENT'S OVERALL PRESSURE INJURY MANAGEMENT PROGRAM. DRIVE WILL CONTINUE TO INVESTIGATE THE INCIDENT.

  Patient problems: Ulcer

  MAUDE report 14106170 ↗
• InjuryJul 12, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  (B)(4) IS THE IMPORTER/ INITIAL DISTRIBUTOR OF THE DEVICE. CAREGIVER ACQUIRED THE DEVICE (B)(6) 2016 FROM A DME PROVIDER. PATIENT USED THE UNIT FOR A MONTH BEFORE SEVERAL BED SORES WERE DISCOVERED. INITIAL TREATMENT WAS IN-HOUSE BY NURSE VISITATION. PATIENT WAS SUBSEQUENTLY ADMITTED TO THE HOSPITAL. PATIENT BEEN IN AND OUT OF THE HOSPITAL TO TREAT BLISTERS. CAREGIVER ADVISED THAT THE UNIT WAS INSTALLED BY DME PROVIDER. THERE IS NO REPORT OF ANY PRODUCT DEFECT AND/OR MALFUNCTION.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 6707408 ↗