NIMBUS 650001ADVRecalls & reported problems
Arjohuntleigh AB · Mattress Cover - Alternating Pressure - Nimbus (Glide IS) Length 2085mm (82"), Width 890mm (35"), Height 215mm (8.5") · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05055982782227), received between Sep 12, 2023 and Sep 12, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Increase in Pressure” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Increase in Pressure1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 12, 2023Increase in Pressure; Increase in Pressure
ARJO BECAME AWARE OF THE NIMBUS 4 MATTRESS OVER-INFLATION. THE MALFUNCTION WAS OBSERVED BY THE CUSTOMER¿S MAINTENANCE TECHNICIAN DURING PREPARING THE MATTRESS FOR USE. NO PATIENT WAS INVOLVED AND NO INJURY OCCURRED. WHEN THE FAILURE OCCURRED, THE FIELD SAFETY CORRECTIVE ACTION WAS NOT COMPLETED ON THE INVOLVED PRODUCT. THE MATTRESS WAS TAKEN OUT OF USE AND QUARANTINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17727020 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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