BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X SERIES

    MDR report key: 13550385 · Received February 17, 2022

    Report

    Report Number
    1220908-2022-00479
    Event Type
    Malfunction
    Date Received
    February 17, 2022
    Date of Event
    January 24, 2022
    Report Date
    January 27, 2022
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    UDI-DI
    00847946019259
    PMA / PMN Number
    P160022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO ZOLL MEDICAL CORPORATION AND THERE WAS NO INDICATION OF A DEVICE MALFUNCTION. THE DEVICE PASSED ALL TESTING WITHOUT DUPLICATING THE REPORT. REVIEW OF THE DEVICE LOG SHOWS THAT THE USER HAD THE DEVICE IN THE INCORRECT ECG VIEW, LEAD I, WHICH DID NOT SHOW THE ECG SIGNAL THROUGH THE PADS. THE LOG CONFIRMS THAT AN ECG SIGNAL WAS OBTAINED THROUGH PADS FOR THE REPORTED TIMEFRAME AND WOULD HAVE BEEN VISIBLE ON THE MONITOR IF THE DEVICE HAD BEEN SWITCHED TO PADS VIEW OR DEFIB MODE WAS ACTIVATED. THE USER WAS ABLE TO UTILIZE THEIR ECG CABLES AND A LEAD SIGNAL WAS DISPLAYED UNTIL THE END OF THE CASE. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE AN (B)(6)-YEAR-OLD FEMALE PATIENT, THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL VIA ELECTRODE PADS. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE AN (B)(6) YEAR-OLD FEMALE PATIENT, THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL VIA ELECTRODE PADS. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1917438 X SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION X SERIES NA 00847946019259

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Female