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

Model Number	P8040H
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The baxter technician found the brake casters needed to be replaced.The baxter transport, procedural, and specialty stretchers are intended for caregivers to use for the treatment and transportation of patients in all areas of the hospital, surgical centers, and other patient care facilities.There are no known contraindications for these stretchers when used in accordance with this instruction for use.A core component of the stretcher braking system is the caster brake.The caster brake is comprised of a hex bar, the cam, the plunger, compressing spring, the brake puck and the wheel.The plunger moving downwards compresses the brake puck against the caster wheel setting the brakes in the system.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 did not show baxter performed any preventative maintenance on this bed.It is unknown if the facility performs preventative maintenance on their beds.The technician replaced the brake casters to resolve the reported event.Based on this information, no further action is required.
Event or Problem Description
Baxter received a report stating that trauma stretcher frame brake casters were not holding.The bed was located at the account.There was no patient/user injury, medical intervention, symptom, or adverse event reported.

• 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, nuevo leon 66640 ; MX 66640
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 22876140
• Report Number: 3006697241-2025-00231
• Device Sequence Number: 17586492
• Product Code: FPO
• UDI-Device Identifier: 00887761000995
• UDI-Public: (01)00887761000995(11)190729
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K961437
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/22/2025

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: Health Professional
• Device Model Number: P8040H
• Device Catalogue Number: P8040H000605
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2019
• 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