BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSTART ELECTRODE CABLE

    MDR report key: 613663 · Received June 14, 2005

    Report

    Report Number
    9610483-2005-00006
    Event Type
    Death
    Date Received
    June 14, 2005
    Date of Event
    January 25, 1999
    Report Date
    January 25, 1999
    Manufacturer
    LAERDAL MEDICAL, A.S.
    Product Code
    LDD
    Removal / Correction Number
    Z805 5
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A CALL IN 1999 INVOLVING A PT IN CARDIAC ARREST, THE UNIT WOULD NOT ALLOW THE EMS CREW TO DEFIBRILLATE A PT WHILE USING THE HANDS FREE CABLES AND 902400 PADS. THE FIRE DEPARTMENT ON THE SCENE WAS ABLE TO SHOCK THE PT WITH THEIR AED. THE PT CONVERTED TO A NON-TREATABLE RHYTHM AND WAS TRANSPORTED A HOSPITAL WHERE THEY WERE PRONOUNCED. THE PADS WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART ELECTRODE CABLE ELECTRODE CABLE LDD LAERDAL MEDICAL, A.S. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death