pro+ P7923A03Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887761977921), received between Nov 1, 2024 and May 8, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Degraded” (1 report).

3 FDA recall records name this device's identifier, 3 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 8, 2024Open, Classified

   There is a potential for the top cover of the hospital bed mattress to delaminate as a result of improper cleaning and lack of adequate details on the appropriate use of cleaning agents containing bleach.

   Z-2151-2024 · Root cause: Error in labeling · FDA record ↗

2. Mar 31, 2023Open, Classified

   There is a potential for mattress cover damage (delamination) which may result in fluid absorption in the mattress (fluid ingress).

   Z-1482-2023 · Root cause: Process change control · FDA record ↗

3. Jun 24, 2022Open, Classified

   The failure mode on the affected mattresses can cause a reduction in the performance of the Microclimate Management feature used to pull heat and moisture away from the patient resulting in an increased patient risk of pressure ulcer development.

   Z-1416-2022 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  BAXTER RECEIVED A REPORT FROM A BAXTER TECHNICIAN TO REPORT THE PRO+ SURFACE - 36" WIDTH POWER CORD HAD COPPER WIRES EXPOSED. THE BED WAS LOCATED AT THE ACCOUNT. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED. THERE WERE NO OTHER DEVICES REPORTED TO BE INVOLVED. THE CUSTOMER DID NOT KNOW IF THIS EVENT WAS ALREADY COMMUNICATED TO ANOTHER BAXTER DEPARTMENT OR AUTHORITY. THE DEVICE WAS REQUESTED FOR SERVICE/INSPECTION BY BAXTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21989120 ↗
• InjuryNov 1, 2024Degraded; Degraded

  IT WAS REPORTED THAT THE SURFACE OF THE PRO+ CENTRELLA MATTRESS PRESENTED DELAMINATION, AND A PATIENT DEVELOPED A STAGE 3 PRESSURE INJURY. THE CUSTOMER NOTED THE SURFACE HAD BEEN CLEANED USING OXIVIR PLUS, A CLEANING AGENT LISTED AS AN APPROVED CLEANER FOR THE MATTRESS. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN SPECIFIC DETAILS ABOUT THE DEVELOPMENT OF THE REPORTED PRESSURE INJURY, EVENTUAL MEDICAL/SURGICAL INTERVENTION REQUIRED, AND ITS CURRENT STAGE; HOWEVER, AT THIS TIME, NO ADDITIONAL INFORMATION COULD BE OBTAINED FROM THE CUSTOMER.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 20587980 ↗