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NIMBUS 650201DARRecalls & reported problems

Arjohuntleigh AB · Mattress Cover - Alternating Pressure - Nimbus (Reliant IS) Length 2085mm (82"), Width 800mm (31.5"), Height 215mm (8.5") · Class 2

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 05055982782258), received between Apr 22, 2021 and Apr 22, 2021 — 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.

  • MalfunctionApr 22, 2021Increase in Pressure; Increase in Pressure

    A MALFUNCTION OF THE NIMBUS 4 SYSTEM WHICH CONSISTS OF MATTRESS (650201DAR, SERIAL NUMBER (B)(4)) AND PUMP (UNKNOWN SERIAL NUMBER) WAS REPORTED TO ARJO BY THE CUSTOMER STAFF. FOLLOWING INFORMATION GATHERED, IT WAS OBSERVED THAT THE MATTRESS STARTED OVERINFLATING AFTER PATIENT¿S REPOSITIONING. THE PATIENT WAS TRANSFERRED TO ANOTHER DEVICE. NO INJURY WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11705077 ↗

Other MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE devices

All MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.