BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X SERIES

    MDR report key: 7390043 · Received April 2, 2018

    Report

    Report Number
    1220908-2018-00871
    Event Type
    Malfunction
    Date Received
    April 2, 2018
    Date of Event
    February 18, 2018
    Report Date
    March 12, 2018
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    K112432
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED TO ZOLL MEDICAL CORPORATION, UNITED STATES. INSTEAD, OUR DISTRIBUTOR RECEIVED THE DEVICE FOR EVALUATION. DURING THE EVALUATION THE CUSTOMER'S REPORT COULD NOT BE REPLICATED OR CONFIRMED. THE MONITOR BOARD WAS REPLACED AS A PRECAUTION. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. THE MONITOR BOARD WAS RETURNED TO ZOLL MEDICAL CORPORATION, UNITED STATES. TESTING OF THE BOARD WAS NOT ABLE TO DUPLICATE THE CUSTOMER'S REPORT. THE DEVICE ACTIVITY LOGS WERE NOT AVAILABLE AS PART OF THIS INVESTIGATION. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED TO ZOLL MEDICAL CORPORTION, UNITED STATES. INSTEAD, OUR DISTRIBUTOR RECEIVED THE DEVICE FOR EVALUATION. DURING THE EVALUATION THE CUSTOMER'S REPORT COULD NOT BE REPLICATED OR CONFIRMED. THE MONITOR BOARD WAS REPLACED AS A PRECAUTION. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. THE MONITOR BOARD WAS RETURNED TO ZOLL MEDICAL CORPORATION, UNITED STATES. TESTING OF THE BOARD WAS NOT ABLE TO DUPLICATE THE CUSTOMER'S REPORT. THE DEVICE ACTIVITY LOGS WERE NOT AVAILABLE AS PART OF THIS INVESTIGATION. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE RESTART/REBOOT ITSELF. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233014 X SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION X SERIES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown