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
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 sacrum.Then on an unknown date, this patient was admitted to the hospital for an unspecified diagnosis.On the date of the event, a deep tissue pressure injury (dtpi) developed inside the preexisting stage 4 wound.No medical intervention was provided.The progress bed was replaced, and the patient developed a second dtpi.No medical intervention was provided for this injury as well.No further information was available at the time of this report.
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.
Additional Manufacturer Narrative
Additional information: d9, h3, h6 h7, h9, and h11.H11: the device was received for evaluation.A nonconformance has been opened to address this issue.In the field investigation, it is alleged that bottom two air bladders on the head section are not inflating properly and when the patient is put on the bed.Furthermore, the bladders move sideways, and it makes a large dip in the mattress when the patient is laying in.Additionally, the bladders are not fully inflated.The cause of the condition is due to manufacturing.Should additional relevant information become available, a supplemental report will be submitted.

• 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: 21304053
• Report Number: 1824206-2025-00189
• Device Sequence Number: 8244129
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2025

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2025
• Supplement Date Received by Manufacturer: 09/19/2025
• Initial Report FDA Received Date: 02/04/2025
• Supplement Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3006697241-02/14/25-001-
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown