BEUDAMED
    FDA Adverse Event Summary report: N

    !!93H PROFLEXX H FRAME COT

    MDR report key: 4891989 · Received July 6, 2015

    Report

    Report Number
    1523574-2015-00064
    Date Received
    July 6, 2015
    Date of Event
    June 29, 2015
    Report Date
    September 14, 2015
    Manufacturer
    FERNO-WASHINGTON, INC.
    Product Code
    FPO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    EMERGENCY MEDICAL TECHNICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL/FUNCTIONAL EVALUATION WAS CONDUCTED ON THE DEVICE BY FERNO'S AUTHORIZED FIELD SERVICE REPRESENTATIVE. A MISSING SPRING WAS OBSERVED BUT NOTHING WAS FOUND AS CONTRIBUTING TO THE REPORTED INCIDENT. THE COT WAS FUNCTIONING ACCORDING TO SPECIFICATION AND THE INCIDENT COULD NOT BE DUPLICATED. NO INJURIES WERE REPORTED AT THE INITIAL REPORT AND NO ADDITIONAL INFORMATION HAS BEEN COMMUNICATED SINCE THAT TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING THE LOADING OF A PATIENT INTO THE AMBULANCE THE STRETCHER WAS LIFTED TO ALLOW THE LEGS TO BE RAISED. THE LEGS ALLEGEDLY WOULD NOT RAISE. THE STRETCHER WAS THEN PLACED BACK ON THE GROUND, ON ALL FOUR WHEELS. IT WAS THEN ALLEGED THE FOOT END OF THE STRETCHER LOWERED WITH THE PATIENT; HOWEVER, THE HEAD END OF THE STRETCHER REMAINED HOOKED INTO THE AMBULANCE. THERE WERE NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437122 !!93H PROFLEXX H FRAME COT 93H PROFLEXX H FRAME COT FPO FERNO-WASHINGTON, INC. 0015747

    Patients

    Seq Age Sex Outcome Treatment
    1