MAUDE Adverse Event Report: HILL-ROM MEXICO TRAUMA STRETCHER FRAME; STRETCHER, WHEELED

Model Number	P8040H000014
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Baxter received a report from a baxter technician stating the brake casters were not holding.The bed was located at the account.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint # (b)(4).
Additional Manufacturer Narrative
The baxter technician found the brake casters needed to be replaced.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 showed baxter performed preventative maintenance on this bed in (b)(6) 2023.It is unknown if the facility performed any other preventative maintenance on this bed.The technician replaced the brake casters to resolve the reported event.Based on this information, no further action is required.

• Brand Name: TRAUMA STRETCHER FRAME
• Common Device Name: STRETCHER, WHEELED
• Manufacturer (Section D): HILL-ROM MEXICO; ave.del telefono no. 200 col. huinala; apodaca, nuevo leon
• Manufacturer Contact: daniela avila ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 18312289
• Report Number: 3006697241-2023-00137
• Device Sequence Number: 6643584
• Product Code: FPO
• UDI-Device Identifier: 00887761000995
• UDI-Public: 010088776100099511180108
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/12/2023

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: P8040H000014
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2023
• Initial Report FDA Received Date: 12/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2018
• 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