MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION SYNERGY SURFACE; BED, FLOTATION THERAPY, POWERED

Model Number	P6881
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	09/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No further information is available on the repair of the bed at this time.The investigation is ongoing, however if any additional relevant information is identified following the completion of the investigation, the additional relevant information will be submitted in a supplemental report.
Event or Problem Description
It was reported that the air cells on the synergy elite mattress are shifting to one side and do not seem to fully inflate and the customer has a new pressure wound.Customer indicated prior history of flap surgery 3 1/2 years ago, did not provide details of location, and about 6-8 months ago patient started with a new pressure sore on the sacrum and it is stage 4.The medical intervention provided for the pressure wound is regular dressing changes and they are going to start using a wound vac and the hyperbaric chamber.It was also reported the patient was transferred to a rehab facility where the expected duration of stay was initially estimated at 6¿8 months but was later revised to approximately 20 days.The patient stated that the mattress was manipulated by a non-baxter employee, did not provide specific date on when this occurred.The person sewed the mattress air cells and after 2-3 months the cells come loose and mattress would separate.Instructions in the ifu are outline users: ¿unzip the top coverlet from the bottom encasement and examine the air cells and air tubes for leaks.If a leak is found, contact baxter technical support for assistance.¿.No further information was available at the time of this report.

• Brand Name: SYNERGY SURFACE
• Common Device Name: BED, FLOTATION THERAPY, POWERED
• 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: 25115542
• Report Number: 1824206-2026-01006
• Device Sequence Number: 18464644
• Product Code: IOQ
• UDI-Device Identifier: 00887761016644
• UDI-Public: (01)00887761016644(11)210503
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/07/2026

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?: No
• Operator of Device: Other
• Device Model Number: P6881
• Device Catalogue Number: P6881CAP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/03/2021
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown