BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERFLEXX POWERED COT

    MDR report key: 4977140 · Received August 6, 2015

    Report

    Report Number
    1523574-2015-00074
    Event Type
    Injury
    Date Received
    August 6, 2015
    Report Date
    September 14, 2015
    Manufacturer
    FERNO-WASHINGTON, INC.
    Product Code
    FPO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    EMERGENCY MEDICAL TECHNICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL/FUNCTIONAL TEST WAS PERFORMED ON THE DEVICE BY FERNO'S AUTHORIZED FIELD SERVICE REPRESENTATIVE. THE REPORTED INCIDENT COULD NOT BE DUPLICATED AND THERE WERE NO MALFUNCTIONS NOTED. THE COT WAS FUNCTIONING ACCORDING TO SPECIFICATION AND WAS RETURNED TO SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE UNLOAD OF A PATIENT FROM THE AMBULANCE THE SAFETY BAR ALLEGEDLY DID NOT FOLD DOWN FROM ITS UPRIGHT POSITION AND DID NOT MAKE CONTACT WITH THE SAFETY HOOK ON THE FLOOR OF THE AMBULANCE. THE COT CAME OUT OF THE BACK OF THE AMBULANCE AND FELL TO THE GROUND. THE COT DID NOT TIP OVER. THE PATIENT WAS SECURED TO THE COT ON A BACKBOARD AND SPINAL IMMOBILIZATION DEVICE. IT WAS REPORTED THE PATIENT'S HEAD BOUNCED AND HIT THE BACK OF THE BOARD AND THE PATIENT ALLEGEDLY COMPLAINED OF LOWER HEAD PAIN. A FOLLOW UP CALL WAS MADE TO CUSTOMER AND THEY STATED THEIR SUPERVISOR DID VISIT THE PATIENT LATER THAT NIGHT AT THE HOSPITAL AND THE PATIENT WAS NOT INJURED FROM THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520914 POWERFLEXX POWERED COT POWERFLEXX POWERED COT FPO FERNO-WASHINGTON, INC. 0015654

    Patients

    Seq Age Sex Outcome Treatment
    1