NIMBUS PROFESSIONAL 651201DARRecalls & reported problems
Arjohuntleigh AB · Mattress Cover - Alternating Pressure - Nimbus Professional (Reliant IS) Length 2085mm (82"), Width 800mm (31.5"), Height 215mm (8.5") · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05055982782210), received between Apr 18, 2023 and Jul 11, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Increase in Pressure” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Increase in Pressure2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 11, 2025Increase in Pressure; Increase in Pressure
DURING THE PRODUCT INSPECTION, THE ARJO TECHNICIAN NOTICED THAT THE AUTOMATT BECAME A BALLOON. THE OVERINFLATION ISSUE WAS NOT ALLEGED BY THE CUSTOMER. THE CUSTOMER ONLY REPORTED THAT THE MATTRESS REQUIRED INSPECTION. THERE WAS NO PATIENT INVOLVED. NO INJURY WAS SUSTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22478911 ↗MalfunctionApr 18, 2023Increase in Pressure; Increase in Pressure
A PATIENT WAS LYING ON THE MATTRESS, WHEN THE AIR CELL INFLATED TOO HARD, CAUSING THE PATIENT TO ROLL TO ONE SIDE. THE SIDERAILS WERE IN RAISED POSITION, PREVENTING THE FALL. NO INJURY WAS SUSTAINED. IN ORDER TO RELEASE THE AIR, THE CUSTOMER CUT THE AUTOMATT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16759906 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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