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

Model Number	P8000H
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per the hillrom 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.Baxter technical support provided the account the part number of the casters that needs to be replaced to resolve the issue.The account will repair the bed themselves.Based on this information, no further action is required.
Event or Problem Description
A customer contacted technical service to report that procedural stretcher frame had casters not holding.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.The customer reported that the product is not available for service/inspection by baxter.

• Brand Name: PROCEDURAL 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 ; 2242705355
• MDR Report Key: 25132051
• Report Number: 3006697241-2026-00172
• Device Sequence Number: 13091868
• Product Code: FPO
• UDI-Device Identifier: 00887761000957
• UDI-Public: (01)00887761000957(11)200529
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K922809
• 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): 05/09/2026

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
• Device Model Number: P8000H
• Device Catalogue Number: P8000H004068
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 05/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2020
• 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