MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION VERSACARE MED SURG BED; BED, FLOTATION THERAPY, POWERED

Model Number	P3201K
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During dea result it was reported that versacare frame had brakes not holding while engaged.This occurred during baxter servicing./testing.There was no patient/user injury, medical intervention, symptom, or adverse event reported.
Additional Manufacturer Narrative
The baxter technician found the four casters needed to be replaced.Per the baxter service manual, perform annual preventive maintenance procedures to make sure all versacare bed components are functioning as originally designed.Brake casters should be checked for cuts, wear and quality of tread, etc.And replaced when necessary.Examine the brakes to see whether the bed moves when the brakes are set.Replace as necessary.A search of the baxter maintenance records showed baxter performed preventative maintenance on this bed in feb 10, 2025.It is unknown if the facility performed any other preventative maintenance on this bed.The technician replaced the four casters to resolve the reported event.Based on this information, no further action is required.

• Brand Name: VERSACARE MED SURG BED
• 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: 24889575
• Report Number: 1824206-2026-00868
• Device Sequence Number: 10330596
• Product Code: IOQ
• UDI-Device Identifier: 00887761000889
• UDI-Public: (01)00887761000889(11)120418
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/15/2026

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: P3201K
• Device Catalogue Number: P3201K000374
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2012
• 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
• Patient Sex: Unknown