Isolibrium 2972 (REF 2972-000-000)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 07613327278453), received between Nov 21, 2018 and Apr 23, 2026 — classified as 5 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (10 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. May 12, 2021Open, Classified

   Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals

   Z-2215-2021 · Root cause: Under Investigation by firm · FDA record ↗

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.

• MalfunctionApr 23, 2026Electrical /Electronic Property Problem

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JANUARY 1- MARCH 31, 2026. THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS(S), WHERE IT WAS REPORTED THE DEVICES EXPERIENCED ACCESSIBLE AC CURRENT. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24966487 ↗
• MalfunctionJan 27, 2026Electrical /Electronic Property Problem

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN OCTOBER 1-DECEMBER 31, 2025. THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICE EXPERIENCED ACCESSIBLE AC CURRENT. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24187836 ↗
• MalfunctionApr 28, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES EXPERIENCED ACCESSIBLE AC CURRENT. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21919239 ↗
• MalfunctionJan 27, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICE EXPERIENCED ACCESSIBLE AC CURRENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21242908 ↗
• InjuryApr 16, 2024Inflation Problem; Adverse Event Without Identified Device or Use Problem; Inflation Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE UNIT "WAS NOT INFLATING AND DEFLATING PROPERLY" AND THAT THIS CAUSED AN UNSPECIFIED PRESSURE INJURY.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 19119853 ↗
• MalfunctionApr 26, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED ACCESSIBLE AC CURRENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16815504 ↗
• InjuryMar 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT SUSTAINED A TYPE 2 PRESSURE INJURY.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 16531252 ↗
• MalfunctionJan 19, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED ACCESSIBLE AC CURRENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13289411 ↗
• InjuryMar 11, 2021Material Too Soft/Flexible; Material Too Soft/Flexible

  IT WAS REPORTED THAT AFTER LAYING ON A DEFLATED MATTRESS OVERNIGHT, THE PATIENT DEVELOPED A PRESSURE INJURY. THE USER FACILITY REPORTED THE PATIENT WAS EVALUATED AND IT WAS DETERMINED THE INJURY WAS CONSISTENT WITH A DTI AND WAS TREATED WITH ADVANCED CAVILON OINTMENT AND MEPILEX FOAM DRESSING.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 11466969 ↗
• InjuryFeb 1, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED PATIENTS ARE EXPERIENCING SKIN BREAKDOWN WHILE USING THE MATTRESSES. NO INFORMATION HAS BEEN PROVIDED REGARDING THE SEVERITY OR TREATMENT OF THE SKIN BREAKDOWN. ATTEMPTS HAVE BEEN MADE TO REACH THE CUSTOMER FOR MORE INFORMATION; HOWEVER, THE CUSTOMER HAS NOT RESPONDED TO THESE ATTEMPTS.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 11261169 ↗
• MalfunctionJan 28, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THERE WAS ACCESSIBLE AC CURRENT.  THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11243345 ↗
• MalfunctionJan 22, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE DEVICE HAD EXPOSED BARE WIRES. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11217592 ↗
• MalfunctionJan 14, 2021Difficult or Delayed Positioning; Difficult or Delayed Positioning

  IT WAS REPORTED THAT THE MAX INFLATE ON THE MATTRESS HAD NOT INFLATED IT TO THE DEGREE A NURSE HAD EXPECTED. THE NURSE TRIED TO BOOST THE PATIENT AND SUSTAINED AN UNSPECIFIED BACK INJURY WHILE DOING SO. NO TREATMENT DETAILS HAVE BEEN PROVIDED. NO IMPACT OR ADVERSE CONSEQUENCE TO THE PATIENT HAS BEEN REPORTED.

  Patient problems: Pain

  MAUDE report 11172632 ↗
• MalfunctionJul 22, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT, WHERE IT WAS REPORTED THERE WAS ACCESSIBLE AC CURRENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10308990 ↗
• MalfunctionApr 27, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT, WHERE IT WAS REPORTED THERE WAS ACCESSIBLE ELECTRIC CURRENT.  THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10001167 ↗
• MalfunctionJan 25, 2019Human-Device Interface Problem; Human-Device Interface Problem

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED IT WAS DIFFICULT TO PERFORM X-RAYS WITH THE MATTRESS. THERE WAS PATIENT INVOLVEMENT, HOWEVER THERE WERE NO CONSEQUENCES OR IMPACTS TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8279085 ↗
• InjuryNov 21, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT'S SKIN BROKE DOWN ON THE MATTRESS.

  Patient problems: Tissue Breakdown

  MAUDE report 8096614 ↗