BEUDAMED
    FDA Adverse Event Death Summary report: N

    M SERIES

    MDR report key: 418934 · Received September 27, 2002

    Report

    Report Number
    1220908-2002-01499
    Event Type
    Death
    Date Received
    September 27, 2002
    Date of Event
    August 25, 2002
    Report Date
    August 27, 2002
    Manufacturer
    ZOLL MEDICAL CORP.
    Product Code
    MKJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT THE MEDICS WERE ATTEMPTING TO RESUSCITATE A PT (AGE AND GENDER UNK) AND, UPON A SEVENTH DEFIBRILLATION ATTEMPT, MEDICS OBSERVED AN ARC AND HEARD A "LOUD BANG" SOUND. MEDICS WERE UTILIZING EXTERNAL PADDLES AND NON-ZOLL GEL-PADS AS A CONDUCTIVE MEDIUM TO DEFIBRILLATE THE PT. SUBSEQUENT TO THE REPORTED PROBLEM, A VISUAL INSPECTION OF THE PT AND THE GEL-PADS INDICATED NO SIGNS OF ARCING OR BURNING TO THE PT. MEDICS OBTAINED ANOTHER DEVICE AND CONTINUED TO TREAT THE PT WITHOUT FURTHER INCIDENT. THE PT SUBSEQUENTLY EXPIRED, BUT THE COMPLAINANT INDICATED THAT THE PT OUTCOME WAS NOT AS A RESULT OF THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORP. MSERIES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death