BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E SERIES DEFIBRILLATOR

    MDR report key: 6178033 · Received December 15, 2016

    Report

    Report Number
    1220908-2016-03121
    Event Type
    Malfunction
    Date Received
    December 15, 2016
    Report Date
    November 28, 2016
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    K042007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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

    THE MALFUNCTION WAS OBSERVED DURING INCOMING TESTING; HOWEVER AFTER DISASSEMBLING THE DEVICE TO DETERMINE ROOT CAUSE, THE MALFUNCTION WAS NO LONGER SEEN. THE DEVICE WAS PUT THROUGH EXTENSIVE TESTING WITHOUT DUPLICATING THE MALFUNCTION. A FLEX CABLE WAS REPLACED AS A PRECAUTION. THE DEVICE PASSED THE FINAL TEST PROCEDURE, WAS RECERTIFIED, AND RETURNED TO THE CUSTOMER. ANALYSIS FOR REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE FAILED SELF TEST. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    827917 E SERIES DEFIBRILLATOR E SERIES MKJ ZOLL MEDICAL CORPORATION E SERIES NA

    Patients

    Seq Age Sex Outcome Treatment
    1