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

Model Number	P8000H
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The baxter technician found the siderail upright needed to be replaced.Per the baxter service manual it is necessary for stretchers to have an effective maintenance program.We recommend that you do annual preventative maintenance.Make sure the side rails are not bent or twisted.Make sure the latch mechanisms operate correctly.You must hear an audible click when the side rail is raised to the up position.Check for loose or missing hardware.Tighten, repair or replace as 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 baxter technician replaced the siderail upright for the customer to resolve the issue.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 siderail false latching.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.

• 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: 25143975
• Report Number: 3006697241-2026-00175
• Device Sequence Number: 13124990
• Product Code: FPO
• UDI-Device Identifier: 00887761000957
• UDI-Public: (01)00887761000957(11)190806
• 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): 05/11/2026

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: P8000H002946
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2019
• 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