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

Model Number	P8040G
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per the baxter service manual it is necessary for stretchers to have an effective maintenance program.We recommend that you do annual preventative maintenance.Inspect the power cord and plug for nicks, cuts, and breaks.A search of the baxter maintenance records showed baxter performed preventative maintenance on this bed in may 15, 2025.It is unknown if the facility performed any other preventative maintenance on this bed.Baxter technical support contacted the account two additional times trying to obtain the resolution for this event.No response has been received from the account.Based on this information, no further action is required.
Event or Problem Description
On 24-nov-2025, a other health care professional contacted technical service to report that trauma stretcher frame (product code p8040g000126, serial number (b)(6)), had power cord damaged with copper wires exposed.This occurred during patient use.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: 24057245
• Report Number: 3006697241-2026-00019
• Device Sequence Number: 10023118
• Product Code: FPO
• UDI-Device Identifier: 00887761000995
• UDI-Public: (01)00887761000995(11)0906/28
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Type of Report: Initial
• Report Date (Section B): 01/13/2026

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
• Operator of Device: Other
• Device Model Number: P8040G
• Device Catalogue Number: P8040G000126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2009
• 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