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

Model Number	P7520A23
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	01/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4: unique identifier (udi) #: the serial number (21) and subsequent manufacturing date (11) are unknown; therefore, the udi number only will contain the device identifier (01).H11: the serial number is unknown.The device was replaced and is currently in good working condition; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported by the customer the bladder in a progressa bed surface was twisting and causing a dip, and a patient injury occurred.During an onsite visit by baxter team members the customer reported the patient had an initial stage 4 pressure sore on the right sacrum.Then on an unknown date, this patient was admitted to the hospital for an unspecified diagnosis.On the date of the event, the stage 4 pressure injury was observed to have ¿worsened¿.Also on this date, while hospitalized, the patient developed a stage 4 pressure injury on the left sacrum.The patient underwent a debridement to both pressure injuries.The patient later recovered from the stage 4 pressure injury leaving the patient with the initial stage 4 pressure injury they were admitted to the hospital with.The customer reported a non-baxter mapping pad was used on the progressa bed surface between the microclimate management (mcm) topper and the air bladders.On an unknown date, the customer replaced the mattress.No further information was available at the time of this report.

• Brand Name: PROGRESSA SURFACE
• 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 ; 2242702068
• MDR Report Key: 21304935
• Report Number: 1824206-2025-00188
• Device Sequence Number: 8876535
• Product Code: FNL
• UDI-Device Identifier: 00887761999855
• UDI-Public: (01)00887761999855
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 02/04/2025

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: P7520A23
• Device Catalogue Number: P7520A23
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2025
• Initial Report FDA Received Date: 02/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: WELL SENSE MAPPING PAD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown