BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X SERIES

    MDR report key: 9622138 · Received January 23, 2020

    Report

    Report Number
    1220908-2020-00045
    Event Type
    Malfunction
    Date Received
    January 23, 2020
    Report Date
    January 3, 2020
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    UDI-DI
    00847946004354
    PMA / PMN Number
    K112432/P160
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO ZOLL MEDICAL CORPORATION; THE DEVICE'S MFC-TO-CPRD CONNECTOR (ADAPTOR) WAS REMOVED AND RETURNED. THE CUSTOMER'S REPORT WAS DUPLICATED AND ATTRIBUTED TO A FAULTY PIN ON A CONNECTOR ON THE MFC-TO-CPRD CONNECTOR. THE MFC-TO-CPRD CONNECTOR WAS REPLACED. THE FAULTY MFC-TO-CPRD CONNECTOR WAS SCRAPPED. ANALYSIS FOR REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO ZOLL MEDICAL CORPORATION FOR EVALUATION. THE CUSTOMER'S REPORT WAS NOT CONFIRMED DURING DEVICE TESTING. THE CPR ADAPTER WAS REPLACED ONSITE BY A ZOLL FIELD REPRESENTATIVE AS A PRECAUTION. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. ANALYSIS OF 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 WAS UNABLE TO OBTAIN AN ECG SIGNAL VIA ELECTRODE PADS. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87396 X SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION X SERIES NA 00847946004354

    Patients

    Seq Age Sex Outcome Treatment
    1