pro+ P7924A01Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00887761977907), received between Oct 26, 2022 and Oct 27, 2022 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Component or Accessory Incompatibility” (4 reports).

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-1411-2022 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 27, 2022Inflation Problem; Component or Accessory Incompatibility; Inflation Problem; Component or Accessory Incompatibility

  THE CUSTOMER REPORTED THAT THE PRO+ MATTRESS WAS COMPRESSED AND THAT AN INCREASE IN THE DEVELOPMENT OF PRESSURE INJURIES WAS ASSOCIATED WITH ITS USE. THE CUSTOMER REPORT COULD NOT ASSOCIATE A PATIENT WITH A SPECIFIC BED/SERIAL NUMBER BUT DID PROVIDE A ROOM NUMBER THE PATIENT OCCUPIED DURING THE HOSPITALIZATION. THE REPORTED INJURIES ASSOCIATED WITH PATIENTS 1- 7 HAVE BEEN EVALUATED SEPARATELY. THIS EVALUATION ADDRESSES PATIENT 6. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15678861 ↗
• InjuryOct 26, 2022Inflation Problem; Component or Accessory Incompatibility; Inflation Problem; Component or Accessory Incompatibility

  THE CUSTOMER REPORTED THAT THE PRO+ MATTRESS WAS COMPRESSED AND THAT AN INCREASE IN THE DEVELOPMENT OF PRESSURE INJURIES WAS ASSOCIATED WITH ITS USE. THE CUSTOMER REPORT COULD NOT ASSOCIATE A PATIENT WITH A SPECIFIC BED/SERIAL NUMBER BUT DID PROVIDE A ROOM NUMBER THE PATIENT OCCUPIED DURING THE HOSPITALIZATION. THE REPORTED INJURIES ASSOCIATED WITH PATIENTS 1- 7 HAVE BEEN EVALUATED SEPARATELY. THIS EVALUATION ADDRESSES PATIENT 2. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15676853 ↗
• InjuryOct 26, 2022Inflation Problem; Component or Accessory Incompatibility; Inflation Problem; Component or Accessory Incompatibility

  THE CUSTOMER REPORTED THAT THE PRO+ MATTRESS WAS COMPRESSED AND THAT AN INCREASE IN THE DEVELOPMENT OF PRESSURE INJURIES WAS ASSOCIATED WITH ITS USE. THE CUSTOMER REPORT COULD NOT ASSOCIATE A PATIENT WITH A SPECIFIC BED/SERIAL NUMBER BUT DID PROVIDE A ROOM NUMBER THE PATIENT OCCUPIED DURING THE HOSPITALIZATION. THE REPORTED INJURIES ASSOCIATED WITH PATIENTS 1- 7 HAVE BEEN EVALUATED SEPARATELY. THIS EVALUATION ADDRESSES PATIENT 3. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS (B)(4).

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 15676806 ↗
• MalfunctionOct 26, 2022Inflation Problem; Component or Accessory Incompatibility; Inflation Problem; Component or Accessory Incompatibility

  THE CUSTOMER REPORTED THAT THE PRO+ MATTRESS WAS COMPRESSED AND THAT AN INCREASE IN THE DEVELOPMENT OF PRESSURE INJURIES WAS ASSOCIATED WITH ITS USE. THE CUSTOMER REPORT COULD NOT ASSOCIATE A PATIENT WITH A SPECIFIC BED/SERIAL NUMBER BUT DID PROVIDE A ROOM NUMBER THE PATIENT OCCUPIED DURING THE HOSPITALIZATION. THE REPORTED INJURIES ASSOCIATED WITH PATIENTS 1- 7 HAVE BEEN EVALUATED SEPARATELY. THIS EVALUATION ADDRESSES PATIENT 5. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 15674732 ↗