BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X SERIES

    MDR report key: 20244591 · Received September 18, 2024

    Report

    Report Number
    1220908-2024-03530
    Event Type
    Malfunction
    Date Received
    September 18, 2024
    Date of Event
    July 21, 2024
    Report Date
    August 28, 2024
    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

    JUSTIFICATION FOR NO UDI: THIS DEVICE WAS MANUFACTURED BUT NOT DOMESTICALLY DISTRIBUTED; IT IS ONLY DISTRIBUTED IN THE INTENDED GEOGRAPHY. THERE IS NO EXISTING UDI REGULATION. ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE PRODUCT FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO ZOLL MEDICAL AUSTRALIA FOR EVALUATION. THE CUSTOMER'S REPORT WAS OBSERVED DURING REVIEW OF THE DEVICE DATA LOGS. HOWEVER, THE DEVICE WAS PUT THROUGH EXTENSIVE FUNCTIONAL TESTING INCLUDING BENCH TESTING WITHOUT DUPLICATING THE REPORT. REVIEW OF THE DEVICE LOGS SHOWED THE UNIT HAD SHUT DOWN AND RESTARTED ON JULY 21, 2024. THE DEVICE RESET COINCIDED WITH RAPID CHANGES IN THE CABLE ID, SUGGESTING A POTENTIAL ISSUE WITH THE MULTI-FUNCTION CABLE (MFC). THIS COULD BE DUE TO A COMPROMISED GASKET OR AN INTERMITTENT ISSUE WITH THE MFC, LEADING TO FLUCTUATIONS BETWEEN THE CABLE PINS AND THE DEVICE RECEPTACLE, WHICH WAS OBSERVED DURING THE ASSESSMENT. THE MFC RECEPTACLE AND MFC CABLE WERE REPLACED AS A PRECAUTION. THE MFC CABLE USED WAS NOT RETURNED AS PART OF THIS INVESTIGATION. 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 · 0

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE INAPPROPRIATELY SHUT DOWN. COMPLAINANT INDICATED THAT THE CLINICIAN POWER CYCLED THE DEVICE TO CONTINUE TREATING THE PATIENT. 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
    1235369 X SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION 610-2221511-13 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown