BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INX FOR INLINE WITH DWL

    MDR report key: 15851788 · Received November 23, 2022

    Report

    Report Number
    1523574-2022-00015
    Event Type
    Injury
    Date Received
    November 23, 2022
    Date of Event
    October 15, 2022
    Report Date
    November 22, 2022
    Manufacturer
    FERNO-WASHINGTON, INC.
    Product Code
    FPO
    UDI-DI
    00190790001339
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE STRETCHER WAS RETURNED TO THE MANUFACTURER AND A VISUAL AND FUNCTIONAL EVALUATION WAS CONDUCTED. BOTH SAFETY BAILS WERE FOUND TO BE FUNCTIONING, AS INTENDED, AND THE STRETCHER ENGAGED WITH THE SAFETY HOOK DURING THE CYCLE AND FUNCTION TEST. THERE WERE NO VISUAL OBSERVATIONS OF IMPACT OR STRIKE MARKS RESULTING FROM THE ALLEGED DROP. IT WAS CONCLUDED, THE STRETCHER WAS OPERATING AS INTENDED. ADDITIONAL UNRELATED OBSERVATIONS CONSISTED OF, A MISSING BOLT IN THE LOAD END LEG CROSSBAR, WORN OPERATOR BUTTONS AND A MISSING SHOCK FRAME PANEL. THE EVALUATION WAS COMPLETED AND ALL WORN AND MISSING COMPONENTS WERE REPLACED. THE STRETCHER WAS RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED WHILE UNLOADING A PATIENT FROM THE AMBULANCE, THE SAFEY BAIL ALLEGEDLY DID NOT ENGAGE WITH THE HOOK ALLOWING THE STRETCHER TO FALL TO THE GROUND. THE PATIENT ALLEGEDLY SUSTAINED AND INJURY AND SOUGHT MEDICAL INTERVENTION. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354853 INX FOR INLINE WITH DWL INX FOR INLINE WITH DWL FPO FERNO-WASHINGTON, INC. 0015811 00190790001339

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Other