MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION EXCEL CARE SURFACE; BARIATRIC BED

Model Number	P624A
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The baxter technician found the power cord needed to be replaced.Per the baxter user manual, perform annual preventive maintenance procedures to make sure all excel care es bariatric bed and excel care bariatric therapy system components are functioning as originally designed.Pay particular attention to safety features such as electrical power cords for fraying, damage, and proper grounding.If damage has occurred to the power cord, immediately remove the bed from service, and contact the applicable maintenance personnel.Failure to do so could cause injury or damage.A search of the baxter maintenance records showed baxter performed preventive maintenance on this bed on july 18, 2025.It is unknown if the facility performed any other preventive maintenance on this bed.The technician replaced the power cord to resolve the reported event.Based on this information, no further action is required.
Event or Problem Description
Baxter received a report stating that excelcare frame power cord had damage with exposed copper wires.The bed was located at the account and occurred before use.There was no patient/user injury, medical intervention, symptom, or adverse event reported.

• Brand Name: EXCEL CARE SURFACE
• Common Device Name: BARIATRIC BED
• 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: 23393469
• Report Number: 1824206-2025-01880
• Device Sequence Number: 15962180
• Product Code: OSI
• UDI-Device Identifier: 00887761013384
• UDI-Public: (01)00887761013384
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/27/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: P624A
• Device Catalogue Number: P624A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2025
• Initial Report FDA Received Date: 10/27/2025
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.
• Patient Sex: Unknown