DRIVEMEDICAL 14001ERecalls & reported problems
Drive Devilbiss Healthcare · Pressure PreventionGroup 1 Surfaces Product Description: APP Sys,Dlx,Variable Pressure,1/ea · Class 2
All models of DRIVEMEDICAL (111)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00822383135809), received between Dec 17, 2019 and Dec 17, 2019 — classified as 1 death.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Death1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathDec 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
(B)(6) HEALTHCARE IS THE IMPORTER OF THE DEVICE WHICH IS AN 14001E ALTERNATING PRESSURE OVERLAY. THE PUMP ATTACHED TO THE SYSTEM WAS NOT A DRIVE MODEL. WE ARE FILING THIS REPORT IN AN OVERABUNDANCE OF CAUTION. THE DECEASED WHILE SUBJECT TO ROUND THE CLOCK CARE WAS IN A BED WITH AN INVACARE PUMP AND A DRIVE 14001E ALTERNATING PRESSURE OVERLAY. A FIRE STARTED IN OR AROUND THE BED. THE DECEASED WAS UNABLE TO CALL FOR HELP OR GET OUT OF THE BED UNASSISTED. HE BURNED IN THE BED. THE FIRE MARSHALL STATES THAT THE FIRE STARTED DUE TO THE PUMP WHICH WAS NOTED AS AN INVACARE UNIT.
Patient problems: Death
MAUDE report 9485110 ↗
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- 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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