BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    35-X PROFLEXX

    MDR report key: 11308479 · Received February 10, 2021

    Report

    Report Number
    1523574-2021-00002
    Event Type
    Malfunction
    Date Received
    February 10, 2021
    Date of Event
    January 31, 2021
    Report Date
    February 10, 2021
    Manufacturer
    FERNO-WASHINGTON, INC.
    Product Code
    FPO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE EVALUATED DUE TO THE AGE OF THE PRODUCT AND THE NATURE OF THE MVA. THE CUSTOMER REPORTED THE STRETCHER WAS DAMAGED AS A RESULT OF THE MVA AND WOULD NOT BE RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED THE AMBULANCE WAS INVOLVED IN A ROLLOVER MOTOR VEHICLE ACCIDENT. DURING THE ACCIDENT, THE STRETCHER ALLEGEDLY BECAME DETACHED FROM THE ANTLER/RAIL FASTENING SYSTEM. THE STRETCHER WAS NOT TRANSPORTING A PATIENT AT THE TIME OF THE ACCIDENT. THE CUSTOMER REPORTED THE STRETCHER WAS DAMAGED AND REMOVED FROM SERVICE. IT WAS REPORTED A MEDIC ALLEGEDLY SUSTAINED MINOR SOFT TISSUE INJURY AS A RESULT OF THE MVA BUT NO ADDITIONAL DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208268 35-X PROFLEXX 35-X PROFLEXX FPO FERNO-WASHINGTON, INC. 0015693

    Patients

    Seq Age Sex Outcome Treatment
    1 Other