BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAIN ASSEMBLY, BLS, ZOLL AED 3, JAPANESE JRC

    MDR report key: 20279563 · Received September 23, 2024

    Report

    Report Number
    1220908-2024-03404
    Event Type
    Malfunction
    Date Received
    September 23, 2024
    Report Date
    September 3, 2024
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    P160022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO ZOLL MEDICAL CORPORATION FOR EVALUATION. THE CUSTOMER'S REPORT WAS VERIFIED AND ATTRIBUTED TO A DAMAGED CONNECTOR ON THE MAIN BOARD. THE MAIN BOARD WAS REPLACED TO RESOLVE THE REPORT. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

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

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE WOULD NOT POWER UP. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1746850 MAIN ASSEMBLY, BLS, ZOLL AED 3, JAPANESE JRC DEFIBRILLATOR MKJ ZOLL MEDICAL CORPORATION 1128-001203-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown