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

Model Number	P7520A23
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	01/31/2025
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 device was not returned and the serial number is unknown; 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.Forty two days prior to this report, the patient developed a deep tissue pressure injury (dtpi) to the left sacrum/buttock.On an unknown date, the patient was admitted to the hospital for an unspecified diagnosis and placed on a progressa bed.After an unspecified amount of time, the dtpi "worsened".The patient underwent a debridement of the wound.At the time of this report, the wound was considered a stage 4 dtpi.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: 21349635
• Report Number: 1824206-2025-00256
• Device Sequence Number: 18106257
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/10/2025

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2025
• Initial Report FDA Received Date: 02/10/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown