MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PROGRESSA+ BED; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number	P7501A
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	01/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported progressa plus bed had an acb (air control board) error fault causing the mattress to deflate which resulted in the patient sustaining a deep tissue pressure injury.The patient received unspecified ¿wound care treatment.¿ multiple attempts were made to the customer to obtain specific details of the reported deep tissue pressure injury, including location, characteristics, and what medical intervention was performed, however no response was received.An inspection performed by a baxter technician noted the supply hose had disconnected.The technician reconnected the supply hose and noted the bed was functioning as designed.No further information was available at the time of this report.
Additional Manufacturer Narrative
H11: the bed was inspected on site by a baxter qualified technician.During visual inspection the technician observed the sleep service hose had been disconnected.The reported condition was verified.The technician reconnected the hose and the bed worked as intended.The cause was due to the hose being disconnected.A service history review was performed and revealed that the device has no previous service events; therefore, servicing did not cause or contribute to the reported event.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PROGRESSA+ BED
• Common Device Name: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): HILL-ROM BATESVILLE; 1069 state route 46 east; batesville IN 47006
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242705355
• MDR Report Key: 24431622
• Report Number: 1824206-2026-00418
• Device Sequence Number: 10393021
• Product Code: FNL
• UDI-Device Identifier: 00887761966925
• UDI-Public: (01)00887761966925(11)990219
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: P7501A
• Device Catalogue Number: P7501A000032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/1999
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown