BEUDAMED
    FDA Adverse Event Death Summary report: N

    IN/X POWERED COT

    MDR report key: 6294352 · Received February 1, 2017

    Report

    Report Number
    1523574-2017-00005
    Event Type
    Death
    Date Received
    February 1, 2017
    Date of Event
    January 30, 2017
    Report Date
    May 26, 2017
    Manufacturer
    FERNO-WASHINGTON, INC.
    Product Code
    FPO
    UDI-DI
    00190790000011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    EMERGENCY MEDICAL TECHNICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL AND FUNCTIONAL EVALUATION WAS CONDUCTED BY AN AUTHORIZED FIELD TECHNICIAN AT THE CUSTOMER'S LOCATION. IT WAS OBSERVED THE CHARGING ACCESSORY IN THE AMBULANCE WAS SITTING TOO HIGH AND WAS NOT MAKING A FULL CONNECTION WITH THE CONTACT POINTS ON THE COT. THE CHARGING SYSTEM WAS ADJUSTED DOWNWARD TO ENSURE FULL CONTACT WAS MADE BETWEEN THE CHARGING SYSTEM AND THE COT. THE COT WAS ALSO EVALUATED AND PASSED ALL INSPECTION POINTS INCLUDING THE OPERATION OF THE MANUAL RELEASE. THE COT IS EQUIPPED WITH A MANUAL MODE TO ALLOW CONTINUED FUNCTION OF THE COT IF THE POWER FAILS. THE ADJUSTMENT OF THE CHARGING SYSTEM IS A COMPONENT THAT NEEDS TO BE INSPECTED ON A REGULAR BASIS DUE TO ITS CONSTANT INTERACTION WITH LOADING AND UNLOADING THE COT. INSTRUCTIONS TO ADJUST, MAINTAIN AND TROUBLESHOOT THE CHARGING SYSTEM IS PROVIDED IN THE USER MANUAL.

    Description of Event or Problem · 1

    IT WAS REPORTED MEDICS WERE CALLED TO A RESIDENCE FOR A NON-RESPONSIVE FEMALE. WHEN THE MEDICS ATTEMPTED TO UNLOAD THE STRETCHER FROM THE AMBULANCE TO TRANSPORT THE PATIENT TO THE HOSPITAL THE POWER MODE WOULD ALLEGEDLY NOT OPERATE DUE TO DEAD BATTERIES. THE CREW DID NOT ATTEMPT TO USE THE MANUAL MODE BUT RATHER CALLED A SECONDARY UNIT TO COMPLETE THE TRANSFER. COMPLAINANT ADVISED THE DELAY DID NOT HINDER THEIR ABILITY TO CARE FOR THE PATIENT AND DID NOT AFFECT THE OUTCOME OF THE PATIENT AS SHE WAS ALREADY IN FULL CARDIAC ARREST AND BEYOND RESUSCITATION UPON THEIR ARRIVAL TO THE SCENE. UPON ARRIVAL TO THE HOSPITAL THE PATIENT WAS DECLARED DECEASED. THE COT WAS REMOVED FROM SERVICE AND THE COMPANY MECHANIC VERIFIED THE ICS CHARGING SYSTEM IN THE AMBULANCE WAS WORKING CORRECTLY. THIS INCIDENT WILL BE INVESTIGATED AND THE BATTERIES INVOLVED WILL BE EVALUATED.

    Description of Event or Problem · 1

    IT WAS REPORTED MEDICS WERE CALLED TO A RESIDENCE FOR A NON-RESPONSIVE FEMALE. WHEN THE MEDICS ATTEMPTED TO UNLOAD THE STRETCHER FROM THE AMBULANCE TO TRANSPORT THE PATIENT TO THE HOSPITAL THE POWER MODE WOULD ALLEGEDLY NOT OPERATE DUE TO DEAD BATTERIES. THE CREW DID NOT ATTEMPT TO USE THE MANUAL MODE BUT RATHER CALLED A SECONDARY UNIT TO COMPLETE THE TRANSFER. COMPLAINANT ADVISED THE DELAY DID NOT HINDER THEIR ABILITY TO CARE FOR THE PATIENT AND DID NOT AFFECT THE OUTCOME OF THE PATIENT AS SHE WAS ALREADY IN FULL CARDIAC ARREST AND BEYOND RESUSCITATION UPON THEIR ARRIVAL TO THE SCENE. UPON ARRIVAL TO THE HOSPITAL THE PATIENT WAS DECLARED DECEASED. THE COT WAS REMOVED FROM SERVICE AND THE COMPANY MECHANIC VERIFIED THE ICS CHARGING SYSTEM IN THE AMBULANCE WAS WORKING CORRECTLY. THIS INCIDENT WILL BE INVESTIGATED AND THE BATTERIES INVOLVED WILL BE EVALUATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77215 IN/X POWERED COT IN/X POWERED COT FPO FERNO-WASHINGTON, INC. 0015802 00190790000011

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Death