MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION TRAUMA STRETCHER; STRETCHER, WHEELED

Model Number	P8040F
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that trauma stretcher frame (product code p8040f000091, serial number (b)(6)), had brakes not holding.The process step during which this occurred was unknown.There was no patient/user injury, medical intervention, symptom, or adverse event reported.
Additional Manufacturer Narrative
The baxter technician found the casters needed to be replaced.Per the baxter service manual the bed should be subject to an effective maintenance program.An annual service of the bed is advised in order to maintain its characteristics and performance.Brake casters should be checked for cuts, wear and quality of tread, etc.And replaced when necessary.Apply the brake and make sure the stretcher does not move.If there is movement, look at the brake components for wear.Apply the steer, and make sure the stretcher steers correctly.Look at the steer components for wear.Put the stretcher in neutral.Make sure all four casters rotate and roll freely.Adjust or replace components if necessary.A search of the baxter maintenance records showed baxter performed preventative maintenance on this bed in jul 26, 2017.It is unknown if the facility performed any other preventative maintenance on this bed.The technician replaced the casters to resolve the reported event.Based on this information, no further action is required.

• Brand Name: TRAUMA STRETCHER
• Common Device Name: STRETCHER, WHEELED
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): HILL-ROM MEXICO; ave.del telefono; no. 200 col. huinala; apodaca 66640 ; MX 66640
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 21927240
• Report Number: 3006697241-2025-00134
• Device Sequence Number: 15711094
• Product Code: FPO
• UDI-Device Identifier: 00887761000995
• UDI-Public: (01)00887761000995(11)080213
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 04/29/2025

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: P8040F
• Device Catalogue Number: P8040F000091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2025
• Initial Report FDA Received Date: 04/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2008
• 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: N/A.
• Patient Sex: Unknown