NIMBUS PROFESSIONAL 651001DARRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 05055982782197), received between Dec 30, 2024 and Oct 28, 2025 — classified as 1 injury, 14 malfunctions.

The most frequently reported specific device problem is “Increase in Pressure” (14 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.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 28, 2025Increase in Pressure; Increase in Pressure

  DURING THE MATTRESS INSPECTION, AN ARJO TECHNICIAN FOUND THE AUTOMATT (MATTRESS BASE) TO BE FAULTY, CAUSING AN OVERINFLATION ISSUE. THERE WAS NO INDICATION OF PATIENT INVOLVEMENT. NO INJURY WAS SUSTAINED. THE FAULTY AUTOMATT WAS REPLACED WITH A NEW ONE, AND THE MATTRESS WAS TESTED. THE MATTRESS WORKED AS INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23400733 ↗
• MalfunctionOct 20, 2025Increase in Pressure; Increase in Pressure

  ARJO BECAME AWARE OF AN INCORRECTLY INFLATED MATTRESS THAT WAS DESCRIBED BY THE CUSTOMER AS ¿INFLATED LIKE A BALL¿. THERE WAS NO INDICATION OF PATIENT INVOLVEMENT, AND NO INJURY WAS SUSTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23334257 ↗
• MalfunctionSep 19, 2025Increase in Pressure; Increase in Pressure

  THE NIMBUS 4 MATTRESS WAS FOUND IN A STORE FOR REPAIR BY AN ARJO TECHNICIAN. THERE WAS NO ALLEGATION OF FAILURE FROM THE CUSTOMER. DURING THE DEVICE INSPECTION, AN ARJO TECHNICIAN FOUND THAT THE AUTOMATT WAS FAULTY, CAUSING THE MATTRESS TO OVERINFLATE. THERE WAS NO INDICATION OF PATIENT INVOLVEMENT, AND NO INJURY WAS REPORTED. THE FAULTY AUTOMATT WAS REPLACED. THE REPAIRED MATTRESS WAS TESTED, AND IT WORKED AS INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23093247 ↗
• MalfunctionSep 18, 2025Increase in Pressure; Increase in Pressure

  ARJO WAS INFORMED ABOUT THE EVENT INVOLVING THE NIMBUS PROFESSIONAL MATTRESS. THE CUSTOMER REPORTED THAT THE MATTRESS DOES NOT WORK CORRECTLY. THERE WAS NO PATIENT INVOLVED. NO INJURY WAS SUSTAINED. DURING THE DEVICE INSPECTION, IT WAS FOUND THAT THE AUTOMATT WAS FAULTY, AND THE OVERINFLATED MATTRESS LOOKED LIKE A BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23083398 ↗
• MalfunctionSep 12, 2025Increase in Pressure; Increase in Pressure

  ARJO WAS INFORMED ABOUT AN EVENT INVOLVING THE NIMBUS PROFESSIONAL MATTRESS. IT WAS REPORTED THAT THE MATTRESS WAS OVERINFLATED, WITH HIGH PRESSURE AND NO VISIBLE ORIGIN. THERE WAS NO INDICATION OF PATIENT INVOLVEMENT, AND NO INJURY WAS SUSTAINED. DURING THE DEVICE INSPECTION, THE ARJO TECHNICIAN FOUND THAT THE OVERINFLATION ISSUE WAS CAUSED BY A FAULTY AUTOMATT, AND REPLACED IT WITH A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23035382 ↗
• MalfunctionAug 28, 2025Increase in Pressure; Increase in Pressure

  ARJO WAS INFORMED ABOUT THE EVENT INVOLVING NIMBUS PROFESSIONAL MATTRESS. THE CUSTOMER REPORTED THAT THE MATTRESS WAS FAULTY AND OVERINFLATED. THERE WAS NO INDICATION OF PATIENT INVOLVEMENT, AND NO INJURY WAS SUSTAINED. DURING THE MATTRESS INSPECTION, AN ARJO TECHNICIAN CONFIRMED A CUSTOMER'S ALLEGATION. THE MATTRESS WAS OVERINFLATED DUE TO THE FAULTY AUTOMATT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22911022 ↗
• MalfunctionAug 14, 2025Increase in Pressure; Increase in Pressure

  IT WAS FOUND DURING NIMBUS PROFESSIONAL MATTRESS INSPECTION THAT THE MATTRESS WAS OVERINFLATED DUE TO AUTOMATT FAILURE. THERE WAS NO INDICATION OF PATIENT INVOLVEMENT. NO INJURY WAS SUSTAINED. THE FAULTY AUTOMATT WAS REPLACED WITH A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22803270 ↗
• MalfunctionAug 14, 2025Increase in Pressure; Increase in Pressure

  THE CUSTOMER NOTIFIED ARJO ABOUT THE NIMBUS PROFESSIONAL MATTRESS'S OVERINFLATION. THIS ISSUE WAS CONFIRMED DURING AN INSPECTION PERFORMED BY AN ARJO ENGINEER. IT WAS FOUND THAT THE MATTRESS WAS OVERINFLATED DUE TO A FAULTY AUTOMATT. THERE WAS NO INDICATION OF PATIENT INVOLVEMENT. NO INJURY WAS SUSTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22802740 ↗
• MalfunctionAug 13, 2025Increase in Pressure; Increase in Pressure

  DURING THE MATTRESS INSPECTION, THE ARJO TECHNICIAN FOUND THAT THE AUTOMATT WAS FAULTY AND OVERINFLATION OCCURRED. THERE WAS NO PATIENT INVOLVED. NO INJURY WAS SUSTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22791401 ↗
• MalfunctionAug 5, 2025Increase in Pressure; Increase in Pressure

  ARJO WAS INFORMED ABOUT THE EVENT RELATED TO THE NIMBUS PROFESSIONAL MATTRESS. THE CUSTOMER REPORTED A MALFUNCTION OF THE MATTRESS, INDICATING THAT IT NO LONGER INFLATES AS EXPECTED. THERE WAS NO INDICATION OF PATIENT INVOLVEMENT. NO INJURY WAS SUSTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22713581 ↗
• MalfunctionAug 5, 2025Increase in Pressure; Increase in Pressure

  ARJO WAS INFORMED ABOUT THE EVENT RELATED TO THE NIMBUS PROFESSIONAL MATTRESS. THE CUSTOMER ASKED FOR A REPAIR DUE TO THE RIGHT SIDE OF THE MATTRESS BEING BLOWN TOO MUCH. THERE WAS NO INDICATION OF PATIENT INVOLVEMENT. NO INJURY WAS SUSTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22713395 ↗
• MalfunctionAug 5, 2025Increase in Pressure; Increase in Pressure

  ARJO WAS INFORMED ABOUT AN EVENT INVOLVING THE NIMBUS PROFESSIONAL MATTRESS. THE CUSTOMER REPORTED THAT THE OVERINFLATION ISSUE WAS IDENTIFIED BY FACILITY STAFF WHILE PREPARING THE BED FOR PATIENT TRANSFER ONTO IT. THE ISSUE WAS DETECTED BEFORE ANY PATIENT INTERACTION. NO PATIENT WAS INVOLVED, AND NO INJURY WAS SUSTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22713128 ↗
• MalfunctionAug 5, 2025Increase in Pressure; Increase in Pressure

  ARJO WAS INFORMED ABOUT AN EVENT INVOLVING THE NIMBUS PROFESSIONAL MATTRESS. THE CUSTOMER REPORTED THAT THE OVERINFLATION ISSUE WAS IDENTIFIED BY FACILITY STAFF WHILE PREPARING THE BED FOR PATIENT TRANSFER. THE ISSUE WAS DETECTED BEFORE ANY PATIENT INTERACTION. NO PATIENT WAS INVOLVED, AND NO INJURY WAS SUSTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22711485 ↗
• InjuryJan 17, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ARJO WAS INFORMED BY THE PATIENT RECEIVING TREATMENT AT HOME ABOUT THE EVENT RELATED TO THE NIMBUS PROFESSIONAL MATTRESS. THE PATIENT'S CONDITION DETERIORATED AT THE TIME OF USE OF THE NIMBUS PROFESSIONAL, AND THE PRESSURE INJURIES DEVELOPED. ACCORDING TO THE ARJO REPRESENTATIVE, THE MATTRESS WAS WORKING WELL (AS INTENDED) AND THE CUSTOMER WAS TRAINED ON HOW TO USE THE NIMBUS PROFESSIONAL ALONG WITH THE DRI-FLOW AND SKIN IQ 365. ARJO WAS INFORMED THAT THE PATIENT IS PARAPLEGIC RECEIVING TREATMENT AT HOME. THE PATIENT HAS HAD PRESSURE SORES IN THE PAST AND IS PRONE TO PRESSURE SORES. AFTER ABOUT A WEEK OF USE OF THE NIMBUS PROFESSIONAL MATTRESS, THE PATIENT DEVELOPED NEW PRESSURE INJURIES. BEFORE THE NIMBUS PROFESSIONAL, THE PATIENT USED ANOTHER MATTRESS (THERAKAIR VISIO) FOR ABOUT 20 YEARS. THE PATIENT DECIDED TO RETURN TO THE THERAKAIR VISIO MATTRESS WHEN THE NEW SORES DEVELOPED. THE PATIENT STATED THAT ONE OF THE PRESSURE INJURIES HEAL AFTER RETURNING TO THE PREVIOUS MATTRESS AND OTHER ONE (AFTER 2 MONTHS) STILL REQUIRED A MESH. THE EVALUATION OF THE CLAIMED DEVICE CONDUCTED BY THE ARJO TECHNICIAN SHOWED THAT THE NIMBUS PROFESSIONAL WAS WORKING PROPERLY AND NO FAULTS WERE FOUND.

  Patient problems: Tissue Breakdown

  MAUDE report 21178065 ↗
• MalfunctionDec 30, 2024Increase in Pressure; Increase in Pressure

  DURING THE MATTRESS INSTALLATION AT THE CUSTOMER FACILITY, THE MATTRESS OVERINFLATION OCCURRED. THERE WAS NO PATIENT INVOLVEMENT AND NO INJURY WAS SUSTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21041380 ↗