MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION OB/GYN STRETCHER; STRETCHER, WHEELED

Model Number	P8050H
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The baxter technician found all four 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 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 all four casters to resolve the reported event.Based on this information, no further action is required.On february 2, 2025, the customer reported to baxter that the brakes are not working.Upon inspection on march 26, 2025 the technician noted the brakes were not holding.Therefore, the aware date of the reportable event of brakes not holding is march 26, 2025.
Event or Problem Description
Baxter received a report from a baxter technician to report the ob/gyn stretcher frame brake casters were not holding.The bed was located at the account.The process step during which this occurred was unknown.There was no patient/user injury, medical intervention, symptom, or adverse event reported.There were no other devices reported to be involved.The customer did not communicate this event to another baxter department or authority.

• Brand Name: OB/GYN 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: 21721952
• Report Number: 3006697241-2025-00081
• Device Sequence Number: 17109124
• Product Code: FPO
• UDI-Device Identifier: 00887761001008
• UDI-Public: (01)00887761001008(11)160725
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/28/2025

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
• Device Model Number: P8050H
• Device Catalogue Number: P8050H000087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2025
• Initial Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2016
• 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