BEUDAMED
    FDA Adverse Event Injury Summary report: N

    35X PROFLEXX X FRAME COT

    MDR report key: 4909368 · Received July 13, 2015

    Report

    Report Number
    1523574-2015-00067
    Event Type
    Injury
    Date Received
    July 13, 2015
    Date of Event
    July 7, 2015
    Report Date
    September 5, 2015
    Manufacturer
    FERNO-WASHINGTON, INC.
    Product Code
    FPO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    EMERGENCY MEDICAL TECHNICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS EVALUATED BY FERNO'S AUTHORIZED FIELD SERVICE REPRESENTATIVE. THE REPORTED INCIDENT COULD NOT BE DUPLICATED BUT OBSERVED DAMAGED AREAS OF THE COT CONFIRM THE COMPLAINT. THE COT WAS 5 YEARS OLD AT THE TIME OF INCIDENT AND EVALUATION. A REVIEW OF PRIOR SERVICE RECORDS REVEALED NO PREVIOUS SERVICE WORK ORDERS. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER. THERE HAVE BEEN NO REPORTS OF LATER CLAIMED INJURIES BY THE PATIENT. A REVIEW OF THE SERIAL NUMBER REVEAL NO PRIOR RELATED COMPLAINTS AGAINST THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNLOAD OF A BARIATRIC PATIENT THE DROP FRAME ALLEGEDLY BENT UPWARD AS THE BAIL CAUGHT THE SAFETY HOOK AND THE HEAD END WHEELS STRUCK THE STEP BUMPER. THE PATIENT ALLEGEDLY REPORTED AN INJURY BUT REFUSED FURTHER TREATMENT. NO FURTHER DETAILS WERE PROVIDED WITH THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454280 35X PROFLEXX X FRAME COT 35X PROFLEXX X FRAME COT FPO FERNO-WASHINGTON, INC. 0015693

    Patients

    Seq Age Sex Outcome Treatment
    1 Other