Med Aire 14029DPRecalls & reported problems
Drive Devilbiss Healthcare · MedAire8"LowAirLoss.w/Defined · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00822383117164), received between Sep 9, 2023 and Sep 9, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Unintended Deflation” (3 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
Device problems
- Unintended Deflation3
Patient problems
- Tissue Breakdown3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 9, 2023Unintended Deflation; Unintended Deflation
DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF A COMPLAINT INVOLVING A PRESSURE PREVENTION MATTRESS WHERE THE PROVIDER REPORTED THAT THE MATTRESS IS "NOT GETTING FIRM ENOUGH AND THE PATIENT IS BOTTOMING OUT AND DEVELOPING WOUNDS." THE PATIENT REQUIRED WOUND CARE SERVICES BY A PHYSICIAN. THE PRODUCT WAS RETURNED TO DRIVE AND THE INVESTIGATION IS NOT YET COMPLETE.
Patient problems: Tissue Breakdown
MAUDE report 17716709 ↗MalfunctionSep 9, 2023Unintended Deflation; Unintended Deflation
DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF A COMPLAINT INVOLVING A PRESSURE PREVENTION MATTRESS WHERE THE PROVIDER REPORTED THAT THE MATTRESS IS "NOT GETTING FIRM ENOUGH AND THE PATIENT IS BOTTOMING OUT AND DEVELOPING WOUNDS." THE PATIENT REQUIRED WOUND CARE SERVICES BY A PHYSICIAN. THE PRODUCT WAS RETURNED TO DRIVE AND THE INVESTIGATION IS NOT YET COMPLETE.
Patient problems: Tissue Breakdown
MAUDE report 17716674 ↗MalfunctionSep 9, 2023Unintended Deflation; Unintended Deflation
DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF A COMPLAINT INVOLVING A PRESSURE PREVENTION MATTRESS WHERE THE PROVIDER REPORTED THAT THE MATTRESS IS "NOT GETTING FIRM ENOUGH AND THE PATIENT IS BOTTOMING OUT AND DEVELOPING WOUNDS." THE PATIENT REQUIRED WOUND CARE SERVICES BY A PHYSICIAN. THE PRODUCT WAS RETURNED TO DRIVE AND THE INVESTIGATION IS NOT YET COMPLETE.
Patient problems: Tissue Breakdown
MAUDE report 17716663 ↗
Other MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE devices
- Medline MDT24A20Medline Industries, Inc. · MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE267 reports
- Medline MDT24A10Medline Industries, Inc. · MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE118 reports
- Guardian GS-2.5-CTurncare Inc · Mattress, Air Flotation, Alternating Pressure2 recalls15 reports
- IsoAir 2941Stryker Corporation · MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE1 recall1 report
- Arise 1000 EX AREXLAL-CUJoerns Healthcare, LLC · Mattress, Air Flotation, Alternating Pressure1 recall0 reports
- Medline MDT24SUPRAAPLMedline Industries, Inc. · MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE42 reports
- Medline MDT24SUPRADPSMedline Industries, Inc. · MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE40 reports
- Synergy® Surface P6881Hill-Rom, Inc. · MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE28 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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