MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION SYNERGY SURFACE; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number	P6880
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: the device was evaluated onsite by a qualified technician.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.The event history log review showed no keystrokes, programming, or use related events that indicated and/or contributed to the reported issue.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.The reported condition was not verified.The patient is going to replace the mattress.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported a customer sustained a pressure sore with a synergy mattress.The user was utilizing the synergy mattress at home.After an unspecified amount of time, the user felt the mattress was ¿sunken in the middle¿ and ¿no error messages or beeping¿ trigged from the bed.The customer went to the emergency room where seven sutures were placed for a pressure injury.Reportedly, the pressure injury was on the sacral/gluteal area and ¿was probably like a stage five, it was down to the artery.¿ the patient was admitted into the hospital where they were treated with triad, hydrophilic wound dressing, and cauterization.The patient was discharged after ¿ten or eleven days¿.No further information was available at the time of this report.

• Brand Name: SYNERGY SURFACE
• Common Device Name: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• 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: 22383810
• Report Number: 1824206-2025-01171
• Device Sequence Number: 17887408
• Product Code: FNM
• UDI-Device Identifier: 00887761016538
• UDI-Public: (01)00887761016538
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/02/2025

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: Lay User/Patient
• Device Model Number: P6880
• Device Catalogue Number: P6880
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 07/02/2025
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NI.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female