BEUDAMED
    FDA Adverse Event Injury Summary report: N

    93-P

    MDR report key: 4254537 · Received October 31, 2014

    Report

    Report Number
    1523574-2014-00021
    Event Type
    Injury
    Date Received
    October 31, 2014
    Date of Event
    October 9, 2014
    Report Date
    October 30, 2014
    Manufacturer
    FERNO-WASHINGTON, INC.
    Product Code
    FPO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT WAS EVALUATED AND TESTED BY (B)(4), ON BEHALF OF THE MFR. THE COT WAS EVALUATED AND WEIGHT TESTED AND NO MALFUNCTIONS WERE DISCOVERED AND THE INCIDENT COULD NOT BE DUPLICATED. THE COT WAS OPERATING WITHIN SPECIFICATIONS AND WAS RETURNED TO SERVICE.

    Description of Event or Problem · 1

    EMTS/FFS WERE ONSITE AT A NURSING HOME FOR TRANSPORT OF A PT TO HOSPITAL. WHILE IN THE LOAD POSITON WITH FRONT WHEELS ON THE MEDIC, THE FOOT END OF THE COT LOWERED. THERE WAS NO REPORTED INJURY TO THE PT BUT A FF'S ARM WAS INJURED AS A RESULT OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698670 93-P 93-P AMBULANCE COT FPO FERNO-WASHINGTON, INC. 0015630

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention