NIMBUS 650001DARRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 05055982782234), received between Sep 9, 2022 and Sep 16, 2026 — classified as 2 deaths, 15 malfunctions.

The most frequently reported specific device problem is “Increase in Pressure” (17 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Increase in Pressure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50786048 ↗
• MalfunctionAug 19, 2026Increase in Pressure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50317278 ↗
• MalfunctionNov 19, 2025Increase in Pressure; Increase in Pressure

  ARJO WAS INFORMED ABOUT AN EVENT INVOLVING THE NIMBUS 4 MATTRESS. THE CUSTOMER REPORTED THAT THE MATTRESS WAS OVERINFLATING AND THAT THE HOSE WAS BROKEN. THERE WAS NO INDICATION OF PATIENT INVOLVEMENT, AND NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23593006 ↗
• MalfunctionOct 20, 2025Increase in Pressure; Increase in Pressure

  ARJO WAS INFORMED ABOUT AN EVENT INVOLVING THE NIMBUS 4 MATTRESS. THE CUSTOMER REPORTED THAT THE MATTRESS WAS OVERINFLATED. THERE WAS NO INDICATION OF PATIENT INVOLVEMENT, AND NO INJURY WAS SUSTAINED. DURING THE DEVICE INSPECTION, AN ARJO TECHNICIAN CONFIRMED THE CUSTOMER'S ALLEGATION. THE INNER TUBE OF THE AUTOMATT WAS FOUND TO BE FAULTY, RESULTING IN THE MATTRESS OVERINFLATING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23334274 ↗
• MalfunctionSep 12, 2025Increase in Pressure; Increase in Pressure

  ARJO WAS INFORMED ABOUT AN EVENT INVOLVING THE NIMBUS 4 MATTRESS. THE CUSTOMER'S ALLEGATION REFERRED TO THE MATTRESS'S OVERINFLATION. HIGH PRESSURE WITH NO VISIBLE ORIGIN WAS REPORTED. THERE WAS NO INDICATION OF PATIENT INVOLVEMENT, AND NO INJURY WAS SUSTAINED. DURING THE MATTRESS INSPECTION, AN ARJO TECHNICIAN FOUND THAT THE AUTOMATT WAS FAULTY AND REPLACED IT WITH A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23035131 ↗
• MalfunctionAug 19, 2025Increase in Pressure; Increase in Pressure

  ARJO WAS INFORMED ABOUT THE EVENT RELATED TO THE NIMBUS 4 MATTRESS. THE CUSTOMER REPORTED THAT THE MATTRESS DID NOT WORK AND WAS OVERINFLATED. THERE WAS NO INDICATION OF PATIENT INVOLVEMENT. NO INJURY WAS SUSTAINED. DURING THE DEVICE INSPECTION, THE TECHNICIAN CONFIRMED THAT THE AUTOMATT WAS OVERINFLATING. THE FAULTY AUTOMATT WAS REPLACED WITH A NEW ONE AND DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22837083 ↗
• MalfunctionAug 14, 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 22803272 ↗
• MalfunctionMay 15, 2025Increase in Pressure; Increase in Pressure

  ARJO WAS INFORMED ABOUT THE EVENT RELATED TO THE NIMBUS 4 MATTRESS. THE CUSTOMER REPORTED THAT "3 MATTRESSES WERE OVERINFLATING IN AN UNSAFE MANNER AND THE BOTTOM OF THE MATTRESS WAS HOT". THERE WAS NO INDICATION OF PATIENT INVOLVEMENT AND NO INJURY WAS REPORTED. THE ARJO TECHNICIAN CHECKED THE DEVICE AND STATED THAT THE MATTRESS WAS OVERINFLATED DUE TO THE FAULTY AUTOMATT, AND IT NEEDED TO BE REPLACED. THE TECHNICIAN DID NOT CONFIRM THE ISSUE RELATED TO THE HEATING OF THE MATTRESS; HOWEVER, THE PUMP MAY HAVE APPEARED WARM DURING OPERATION, AS IT WAS CONTINUOUSLY SUPPLYING AIR TO THE MATTRESS AS PART OF ITS NORMAL FUNCTION. THE COMPLAINT (B)(4) (MANUFACTURER REPORT NO: 3005619970-2025-00017) REFERS TO THE MATTRESS WITH SERIAL NUMBER: (B)(6), THE COMPLAINT (B)(4) (MANUFACTURER REPORT NO: 3005619970-2025-00019) REFERS TO THE MATTRESS WITH SERIAL NUMBER: (B)(6), THE COMPLAINT (B)(4) (MANUFACTURER REPORT NO: 3005619970-2025-00018) REFERS TO THE MATTRESS WITH SERIAL NUMBER: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22026129 ↗
• MalfunctionMay 15, 2025Increase in Pressure; Increase in Pressure

  ARJO WAS INFORMED ABOUT THE EVENT RELATED TO THE NIMBUS 4 MATTRESS. THE CUSTOMER REPORTED THAT "3 MATTRESSES WERE OVERINFLATING IN AN UNSAFE MANNER AND THE BOTTOM OF THE MATTRESS WAS HOT". THERE WAS NO INDICATION OF PATIENT INVOLVEMENT AND NO INJURY WAS REPORTED. THE ARJO TECHNICIAN CHECKED THE DEVICE AND STATED THAT THE MATTRESS WAS OVERINFLATED DUE TO THE FAULTY AUTOMATT, AND IT NEEDED TO BE REPLACED. THE TECHNICIAN DID NOT CONFIRM THE ISSUE RELATED TO THE HEATING OF THE MATTRESS; HOWEVER, THE PUMP MAY HAVE APPEARED WARM DURING OPERATION, AS IT WAS CONTINUOUSLY SUPPLYING AIR TO THE MATTRESS AS PART OF ITS NORMAL FUNCTION. THE COMPLAINT (B)(4) (MANUFACTURER REPORT NO: 3005619970-2025-00017) REFERS TO THE MATTRESS WITH SERIAL NUMBER: (B)(6), THE COMPLAINT (B)(4) (MANUFACTURER REPORT NO: 3005619970-2025-00019) REFERS TO THE MATTRESS WITH SERIAL NUMBER: (B)(6), THE COMPLAINT (B)(4) (MANUFACTURER REPORT NO: 3005619970-2025-00018) REFERS TO THE MATTRESS WITH SERIAL NUMBER: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22026026 ↗
• MalfunctionMay 15, 2025Increase in Pressure; Increase in Pressure

  ARJO WAS INFORMED ABOUT THE EVENT RELATED TO THE NIMBUS 4 MATTRESS. THE CUSTOMER REPORTED THAT "3 MATTRESSES WERE OVERINFLATING IN AN UNSAFE MANNER AND THE BOTTOM OF THE MATTRESS WAS HOT". THERE WAS NO INDICATION OF PATIENT INVOLVEMENT AND NO INJURY WAS REPORTED. THE ARJO TECHNICIAN CHECKED THE DEVICE AND STATED THAT THE MATTRESS WAS OVERINFLATED DUE TO THE FAULTY AUTOMAT, AND IT NEEDED TO BE REPLACED. THE TECHNICIAN DID NOT CONFIRM THE ISSUE RELATED TO THE HEATING OF THE MATTRESS. THE COMPLAINT (B)(4) (MANUFACTURER REPORT NO: 3005619970-2025-00017) REFERS TO THE MATTRESS WITH SERIAL NUMBER: (B)(6), THE COMPLAINT (B)(4) (MANUFACTURER REPORT NO: 3005619970-2025-00019) REFERS TO THE MATTRESS WITH SERIAL NUMBER: (B)(6), THE COMPLAINT (B)(4) (MANUFACTURER REPORT NO: REFERS TO THE MATTRESS WITH SERIAL NUMBER: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22024582 ↗
• MalfunctionApr 3, 2025Increase in Pressure; Increase in Pressure

  THE CUSTOMER REPORTED THAT THE NIMBUS 4 MATTRESS WAS DEFECTIVE. IT WAS CLAIMED THAT THE LEFT SIDE OF THE MATTRESS WAS RAISED DURING INFLATION. THE ARJO TECHNICIAN INSPECTED THE DEVICE AND FOUND THAT THE AUTOMATT WAS FAULTY. THERE WAS NO INDICATION OF PATIENT INVOLVEMENT, AND NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21759651 ↗
• MalfunctionOct 30, 2024Increase in Pressure; Increase in Pressure

  THE CUSTOMER REPORTED THAT "MATTRESS OVERINFLATION NONSTOP, WHICH CREATES A BUBBLE UNDER THE MATTRESS." THE PROVIDED PHOTOS CONFIRMED THE CUSTOMER'S ALLEGATION. THE MATTRESS SURFACE RAISED AND TILTED TO ONE SIDE. THERE WAS NO PATIENT ON THE MATTRESS, NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20566413 ↗
• MalfunctionJun 21, 2023Increase in Pressure; Increase in Pressure

  ARJO BECAME AWARE OF THE NIMBUS 4 MATTRESS MALFUNCTION. AUTOMATT OVERINFLATION WAS REPORTED. NO PATIENT WAS INVOLVED AND NO INJURY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17169954 ↗
• MalfunctionMay 16, 2023Increase in Pressure; Increase in Pressure

  THE PATIENT REPORTED THAT THE MATTRESS OVERINFLATED AND THE PATIENT FELL FROM THE MATTRESS. THERE WAS NO SERIOUS INJURY. THE PATIENT'S SUSTAINED A LACERATION TO THE HEAD WHICH ONLY REQUIRED FIRST AID MEASURES.

  Patient problems: Laceration(s)

  MAUDE report 16937352 ↗
• MalfunctionNov 2, 2022Increase in Pressure; Increase in Pressure

  ARJO BECAME AWARE OF THE NIMBUS MATTRESS MALFUNCTION. THE CUSTOMER STAFF CLAIMED THE MATTRESS OVER-INFLATION. THE ISSUE WAS DETECTED AT THE TIME OF PREPARING THE DEVICE FOR USE (AFTER INFLATION). NO PATIENT WAS INVOLVED. NO INJURY WAS CLAIMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15714114 ↗
• DeathSep 9, 2022Increase in Pressure; Increase in Pressure

  ARJO BECAME AWARE OF AN EVENT INVOLVING A NIMBUS 4 MATTRESS. A PARAPLEGIC PATIENT FELL OUT OF THE MATTRESS AND WAS FOUND ON THE FLOOR. HE WAS LIFTED BACK INTO THE BED USING THE HOIST. THE PATIENT'S CONDITION HAD PROGRESSIVELY DETERIORATED AND THE PATIENT PASSED AWAY.

  Patient problems: Fall

  MAUDE report 15389655 ↗
• DeathSep 9, 2022Increase in Pressure; Increase in Pressure

  ARJO BECAME AWARE OF AN EVENT INVOLVING A NIMBUS 4 MATTRESS. ACCORDING TO THE REPORT FORWARDED BY THE POLICE TO ARJO, A PARAPLEGIC PATIENT FELL OUT OF THE MATTRESS AND WAS FOUND ON THE FLOOR. HE WAS LIFTED BACK INTO THE BED USING THE HOIST. THE PATIENT'S CONDITION HAD PROGRESSIVELY DETERIORATED AND THE PATIENT PASSED AWAY. THE NIMBUS MATTRESSES CONSIST OF A TOP COVER WHICH COVERS THE MATTRESS SUPPORT SURFACE CONSISTING OF THE SHEET WITH AIR-FILLED CELLS UNDER WHICH IS LOCATED THE AUTOMATT SENSOR PAD (MATTRESS BASE). BASED ON THE PHOTOGRAPHIC EVIDENCE PROVIDED, THE MATTRESS WAS OVER-INFLATED WHAT CONTRIBUTED TO THE PATIENT FALL FROM THE DEVICE.

  Patient problems: Fall

  MAUDE report 15389653 ↗