BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E SERIES DEFIBRILLATOR

    MDR report key: 7228403 · Received January 30, 2018

    Report

    Report Number
    1220908-2018-00185
    Event Type
    Malfunction
    Date Received
    January 30, 2018
    Report Date
    January 9, 2018
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    UDI-DI
    00847946009670
    PMA / PMN Number
    K042007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE PRODUCT FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL MEDWATCH REPORT IS REPORTING THE EVALUATION OF THE DEVICE. THIS SUPPLEMENTAL MEDWATCH REPORT IS ALSO CORRECTING INFORMATION SUBMITTED ON THE INITIAL MEDWATCH REPORT. DEVICE EVALUATION: THE DEVICE WAS RETURNED TO ZOLL MEDICAL CORPORATION; THE MALFUNCTION WAS DUPLICATED AND ATTRIBUTED TO THE LITHIUM BATTERY ON THE SYSTEM BOARD. THE DEVICE OPERATOR'S GUIDE INSTRUCTS USERS TO REPLACE THE LITHIUM BATTERY ON THE DEVICE EVERY 5 YEARS. THIS DEVICE IS APPROXIMATELY 11 YEARS OLD. 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 DISPLAYED AN UNKNOWN ERROR MESSAGE AND WAS UNABLE TO POWER ON FULLY. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION. PLEASE REFERENCE MEDWATCH REPORT NUMBERS 1220908-2018-00180, 1220908-2018-00187, 1220908-2018-00188, 1220908-2018-00109, AND 1220908-2018-00138 FOR A SIMILAR EVENT REPORTS FROM THE SAME CUSTOMER.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE WAS UNABLE TO POWER ON. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION. PLEASE REFERENCE MEDWATCH REPORT NUMBERS 1220908-2018-00180, 1220908-2018-00187, 1220908-2018-00188, 1220908-2018-00109, AND 1220908-2018-00138 FOR A SIMILAR EVENT REPORTS FROM THE SAME CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71893 E SERIES DEFIBRILLATOR E SERIES MKJ ZOLL MEDICAL CORPORATION E SERIES NA 00847946009670

    Patients

    Seq Age Sex Outcome Treatment
    1