BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M SERIES

    MDR report key: 1232303 · Received November 12, 2008

    Report

    Report Number
    1232303
    Event Type
    Malfunction
    Date Received
    November 12, 2008
    Date of Event
    November 2, 2008
    Report Date
    November 12, 2008
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US

    Narratives

    Description of Event or Problem · 1

    CODE BLUE WAS CALLED ON THE PATIENT. THE PHYSICIAN WAS AT BEDSIDE. THE PATIENT WAS ATTACHED TO ZOLL PADS AND CONNECTED TO A ZOLL MONITOR. THE MONITOR REPORTED "POOR PAD CONTACT". ZOLL PADS WERE RECHECKED AND THEN REPLACED. THE DEFIBRILLATOR MACHINE WAS REPLACED WHICH WORKED NORMALLY. CPR WAS NOT INTERRUPTED FOR MORE THAN ONE MINUTE DURING CHECKS ON THE PADS AND MACHINE. PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M SERIES DEFIBRILLATOR MKJ ZOLL MEDICAL CORPORATION M SERIES *

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR CARDIAC DRUGS| CARDIAC DRUGS