BEUDAMED
    FDA Adverse Event Death Summary report: N

    PD4410 1400 SERIES BATTERY PACK

    MDR report key: 88553 · Received May 2, 1997

    Report

    Report Number
    1220908-1997-00081
    Event Type
    Death
    Date Received
    May 2, 1997
    Date of Event
    March 2, 1997
    Report Date
    May 2, 1997
    Manufacturer
    ZOLL MEDICAL CORP.
    Product Code
    LDD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PARAMEDIC

    Narratives

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT THE PARAMEDIC CREW WAS CALLED TO TREAT A 68 YEAR OLD MALE PATIENT WITH DIFFICULTY BREATHING. THE DISPATCHER ADVISED THE ENROUTE CREW THAT CPR WAS BEING PERFORMED ON THE PATIENT. UPON ARRIVAL THE CREW MONITORED THE PATIENT. THE MONITOR INDICATED THAT THE PATIENT WAS IN VENTRICULAR FIBRILLATION. THE CREW ATTEMPTED TO CHARGE THE PADDLES, BUT NO CHARGE OCCURRED. THE CREW SHUT OFF THE MONITOR AND THE TURNED IT BACK ON. VENTRICULAR FIBRILLATION WAS AGAIN CONFIRMED. THEY ATTEMPTED TO CHARGE THE PADDLES A SECOND TIME WITHOUT SUCCESS. THE BACK-UP BATTERIES WERE THEN INSTALLED INTO THE UNIT. AND THE UNIT SUCCESSFULLY CHARGED THE PADDLES. THE PATIENT WAS DEFIBRILLATED AT 200, 300, AND 360 JOULES WITH NO PROBLEMS. THE PATIENT SUBSEQUENTLY EXPIRED. THERE IS NO INDICATION THAT THE ALLEGED MALFUNCTION CONTRIBUTED TO THE PATIENT OUTCOME. PLEASE REFERENCE MEDWATCH REPORT NUMBER 1011006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PD4410 1400 SERIES BATTERY PACK BATTERY LDD ZOLL MEDICAL CORP. PD4410 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death