BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    PRIME 5TH WHEEL STRETCHER 26IN

    MDR report key: 11239166 · Received January 27, 2021

    Report

    Report Number
    0001831750-2021-00317
    Event Type
    Malfunction
    Date Received
    January 27, 2021
    Date of Event
    October 1, 2020
    Report Date
    March 12, 2021
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    UDI-DI
    07613327278149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE THAT WAS PENDING EVALUATION WAS NOT MADE AVAILABLE BY THE CUSTOMER; THE REPORTED ISSUE WAS NOT CONFIRMED.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE STEER MECHANISM IS DIFFICULT TO ENGAGE/DISENGAGE.  THERE WAS NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. 1 DEVICE WAS FUNCTIONALLY/VISUALLY INSPECTED IN THE FIELD. THIS DEVICE WAS REPAIRED AND RETURNED TO USE. 1 DEVICE WAS NOT INSPECTED, AS THE ISSUE WAS IDENTIFIED AND RESOLVED DURING A TROUBLESHOOTING CALL BETWEEN THE CUSTOMER AND STRYKER TECHNICAL SUPPORT. 1 DEVICE IS PENDING INVESTIGATION. THERE WAS NO REMEDIAL ACTION TAKEN. THIS DEVICE IS NOT LABELED FOR SINGLE USE.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE STEER MECHANISM IS DIFFICULT TO ENGAGE/DISENGAGE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134225 PRIME 5TH WHEEL STRETCHER 26IN STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO 1105 07613327278149

    Patients

    Seq Age Sex Outcome Treatment
    1