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

Model Number	P8020H
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During servicing by baxter, technical service identified that electric stretcher frame had a damaged power cord with exposed copper wires showing.This occurred during baxter servicing/testing.There was no patient/user injury, medical intervention, symptom, or adverse event reported.There were no other devices reported to be involved.
Additional Manufacturer Narrative
The baxter technician determined the power cord needed to be replaced.The transport, procedural, and specialty stretchers are intended for caregivers to use for the treatment and transportation of patients in all areas of the hospital, surgical centers, and other patient care facilities.A search of the baxter maintenance records showed baxter performed preventive maintenance on this bed on 30 mar 2024.It is unknown if the facility performed any other preventive maintenance on this bed.The power cord was replaced to resolve.Based on this information no further actions are required.Although there was no reported injury with this event, if the report of a power cord with exposed copper wires were to recur, it could potentially cause serious injury or death.Therefore baxter is reporting this event.

• 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 66640 ; MX 66640
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 20880766
• Report Number: 3006697241-2024-00170
• Device Sequence Number: 18352665
• Product Code: FPO
• UDI-Device Identifier: 00887761000988
• UDI-Public: (01)00887761000988(11)170120
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/09/2024

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: P8020H
• Device Catalogue Number: P8020H000127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2024
• Initial Report FDA Received Date: 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.
• Patient Sex: Unknown