BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    35X PROFLEXX AMBULANCE COT

    MDR report key: 3925283 · Received June 23, 2014

    Report

    Report Number
    1523574-2014-00010
    Event Type
    Malfunction
    Date Received
    June 23, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 12, 2014
    Manufacturer
    FERNO-WASHINGTON, INC.
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON REVIEW OF THE SERVICE EVAL, IT WAS AGREED THAT THE INCIDENT WAS NOT A FAULT OF A MFG DEFECT, BUT RATHER THE LACK OF A MAINTENANCE PLAN. WE ARE REPORTING THE EVENT THOUGH DUE TO THE INTERRUPTION IN SERVICE.

    Description of Event or Problem · 1

    THE EMT UNIT WAS ATTEMPTING TO UNLOAD A PT WITH A KNEE INJURY WAS UNABLE TO GET THE LEGS TO RELEASE ON THE COT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364918 35X PROFLEXX AMBULANCE COT 35X PROFLEXX AMBULANCE COT FPO FERNO-WASHINGTON, INC. 0015690

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR