BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E SERIES DEFIBRILLATOR

    MDR report key: 5545003 · Received April 4, 2016

    Report

    Report Number
    1220908-2016-00835
    Event Type
    Malfunction
    Date Received
    April 4, 2016
    Report Date
    March 17, 2016
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    K042007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS RECEIVED THE PRODUCT AND WILL BE PROVIDING A FOLLOW-UP REPORT WHEN OUR INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW UP MEDWATCH REPORT IS REPORTING THE EVALUATION OF THE DEVICE. THIS FOLLOW UP MEDWATCH REPORT IS ALSO CORRECTING INFORMATION SUBMITTED ON THE INITIAL MEDWATCH REPORT. THE DEVICE WAS RETURNED TO ZOLL MEDICAL CORPORATION; THE MALFUNCTION WAS DUPLICATED AND ATTRIBUTED TO THE MULTI-FUNCTION SIGNAL CABLE. THE MULTI-FUNCTION SIGNAL CABLE WAS REPLACED TO RESOLVE THE MALFUNCTION. ANALYSIS FOR REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING BIOMED TESTING THE DEVICE WAS UNABLE TO DISPLAY AN ECG SIGNAL. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING BIOMED TESTING THE DEVICE DISPLAYED ARTIFACT IN PADS MODE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199559 E SERIES DEFIBRILLATOR E SERIES MKJ ZOLL MEDICAL CORPORATION E SERIES NA

    Patients

    Seq Age Sex Outcome Treatment
    1