BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL MEDICAL CORP.

    MDR report key: 202897 · Received December 18, 1998

    Report

    Report Number
    202897
    Event Type
    Malfunction
    Date Received
    December 18, 1998
    Date of Event
    December 11, 1998
    Report Date
    December 15, 1998
    Manufacturer
    ZOLL MEDICAL CORP.
    Product Code
    LDD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    PARAMEDIC

    Narratives

    Description of Event or Problem · 1

    THE PT WAS SHOCKED THREE TIMES WITH THE ZOLL M-SERIES DEFIBRILLATOR. DURING EACH SHOCK THE ELECTROCARDIOGRAM WAVE-FORM WOULD NOT RECOVER IN AN AMPLE AMOUNT OF TIME TO PROGRESS WITH THE TREATMENT. THE UNIT HAD TO BE SHUT OFF AND TURNED BACK ON AFTER EACH SHOCK IN ORDER TO RECOVER THE ELECTROCARDIOGRAM INFO COMPLETELY. AFTER THE THIRD SHOCK, THE DISPLAY SCREEN FAILED AND WENT COMPLETELTY BLACK. THE RECORDER CONTINUED TO OPERATE BUT WAS DISCONNECTED SO ANOTHER DEFIBRILLATOR (PHYSIOCONTROL LP10) WAS CONNECTED. THE LAST SHOCK WAS ADMINISTERED WITH THE PHYSIO CONTROL DEFIBRILLATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZOLL MEDICAL CORP. DEFIBRILLATOR LDD ZOLL MEDICAL CORP. M-SERIES *

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR