BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X SERIES

    MDR report key: 15478298 · Received September 24, 2022

    Report

    Report Number
    1220908-2022-03573
    Event Type
    Malfunction
    Date Received
    September 24, 2022
    Report Date
    September 5, 2022
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    P160022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO A ZOLL APPROVED SERVICE PROVIDER FOR EVALUATION. THE CUSTOMER'S REPORT WAS OBSERVED DURING REVIEW OF THE DEVICE DATA LOGS. HOWEVER, THE DEVICE WAS PUT THROUGH EXTENSIVE TESTING INCLUDING BENCH HANDLING AND FULL FUNCTIONAL STRESS TESTING WITHOUT DUPLICATING THE REPORT. THE MILTIFUNCTION CABLE (MFC) AND MFC RECEPTACLE WERE REPLACED AS A PRECAUTION. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. THE MFC AND MFC RECEPTACLE WERE RETURNED TO ZOLL MEDICAL CORPORATION AND SCRAPPED. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE DISPLAYED A "ECG MONITORING FAILURE" MESSAGE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1604168 X SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION X SERIES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown