BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1600 SEMI AUTOMATIC DEFIBRILLATOR

    MDR report key: 203024 · Received December 18, 1998

    Report

    Report Number
    1220908-1998-00989
    Event Type
    Malfunction
    Date Received
    December 18, 1998
    Date of Event
    October 25, 1998
    Report Date
    November 19, 1998
    Manufacturer
    ZOLL MEDICAL CORP.
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT THE MEDICS WERE MONITORING A PT (AGE AND GENDER UNKNOWN), WHO WAS PRESENTING A HEART RATE OF 70 BEATS PER MINUTE, BUT THE DEVICE INCORRECTLY DISPLAYED A HEART RATE OF AROUND 150 BEATS PER MINUTE AND THEN A HEART RATE OF AROUND 50 BEATS PER MINUTE. THERE WAS NO INDICATION OF ANY ADVERSE EFFECT ON THE PT AS A RESULT OF THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1600 SEMI AUTOMATIC DEFIBRILLATOR DEFIBRILLATOR MKJ ZOLL MEDICAL CORP. 1600 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other