BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PD 1400 DEFIBRILLATOR/PACEMAKER

    MDR report key: 67944 · Received February 4, 1997

    Report

    Report Number
    1220908-1997-00011
    Event Type
    Malfunction
    Date Received
    February 4, 1997
    Report Date
    February 4, 1997
    Manufacturer
    ZOLL MEDICAL CORP.
    Product Code
    LDD
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S BIOMED DEPARTMENT WAS UNABLE TO DUPLICATE THE ALLEGED MALFUNCTION. THE DEVICE WAS PLACED BACK INTO SERVICE BY THE CUSTOMER, WITHOUT AN EVALUATION BY THE ZOLL TECHNICAL SERVICE DEPARTMENT.

    Description of Event or Problem · 1

    COMPLAINT ALLEGES THAT THE DEVICE (BATTERY POWERED) WAS BEING USED TO DEFIBRILLATE A PT (AGE AND GENDER UNKNOWN.) THE FIRST AND SECOND SHOCKS WERE DELIVERED AT 200J WITH NO PROBLEMS. ON THE THIRD SHOCK, THE DEVICE WAS CHARGED TO 360J, AND SHUT DOWN. THE COMPLAINANT WAS UNSURE AS TO WHAT ACTION WAS TAKEN AFTER SHUTDOWN. NO ADVERSE PT EFFECT WAS REPORTED. BIOMED TESTED BOTH THE DEVICE AND THE BATTERY (SERIAL NUMBER 39-96-0464), BUT WERE UNABLE TO DUPLICATE THE ALLEGED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PD 1400 DEFIBRILLATOR/PACEMAKER DEFIBRILLATOR LDD ZOLL MEDICAL CORP. PD1400 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other