BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    R SERIES DEFIBRILLATOR

    MDR report key: 18942497 · Received March 20, 2024

    Report

    Report Number
    1220908-2024-01033
    Event Type
    Malfunction
    Date Received
    March 20, 2024
    Date of Event
    February 28, 2024
    Report Date
    February 29, 2024
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    UDI-DI
    00847946017408
    PMA / PMN Number
    P160022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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

    THE DEVICE WAS RETURNED TO ZOLL MEDICAL CORPORATION FOR EVALUATION. THE CUSTOMER'S REPORT WAS OBSERVED AND ATTRIBUTED TO TORN WIRING ON THE ELECTRODE PADS. REVIEW OF THE PROVIDED PICTURES DID CONFIRM THE HIGH VOLTAGE WIRE WAS TORN, WHICH WILL PREVENT THE DEVICE FROM DELIVERING A SHOCK. THE PICTURES SHOWED THE ELECTRODES PACKAGE WAS OPENED AT THE CORNER OF THE PACKAGE INSTEAD OF THE SIDE WITH THE YELLOW ARROW. IT IS ADVISED THAT THE PACKAGE IS OPENED ACCORDING TO THE IFU. THE EVENT ELECTRODE PADS WERE NOT RETURNED TO ZOLL. THE DEVICE PASSED ALL FUNCTIONAL TESTING AND DEFIB SHOCK TESTING USING A KNOWN GOOD SET OF TEST PADS. 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 DEFIBRILLATE A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE FAILED TO DISCHARGE. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER SET OF PADS 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
    1985755 R SERIES DEFIBRILLATOR DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION R SERIES NA 00847946017408

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown