BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X SERIES

    MDR report key: 10260538 · Received July 10, 2020

    Report

    Report Number
    1220908-2020-02030
    Event Type
    Malfunction
    Date Received
    July 10, 2020
    Date of Event
    June 15, 2020
    Report Date
    June 19, 2020
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    UDI-DI
    00847946006389
    PMA / PMN Number
    K112432/P160
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED TO ZOLL MEDICAL CORPORATION. INSTEAD, THE DATA FILE FROM THE EVENT WAS RECEIVED. REVIEW OF THE DATA FILE SHOWED MESSAGES INDICATING A LOSS OF ECG SIGNAL. HOWEVER, WITHOUT RECEIPT OF THE DEVICE, CABLE, AND ADAPTER A ROOT CAUSE CANNOT BE ESTABLISHED. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED TO ZOLL MEDICAL CORPORATION FOR EVALUATION. INSTEAD, A MULTIFUNCTION CABLE AND CPR ADAPTER WERE PROVIDED. THE REPORTED MALFUNCTION WAS NOT REPLICATED. THE MULTIFUNCTION CABLE AND CPR ADAPTOR WERE PUT THROUGH EXTENSIVE TESTING INCLUDING FUNCTIONAL TESTING USING A TEST DEVICE WITHOUT DUPLICATING A MALFUNCTION. CONTINUITY TESTING AND VISUAL INSPECTION FOUND NO DISCREPANCIES. THE MULTIFUNCTION CABLE AND CPR ADAPTOR WERE SCRAPPED. REVIEW OF THE DATA LOG IDENTIFIED TYPICAL USER ADVISORIES RELATED TO LOSS OF THE ECG SIGNAL. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL VIA ELECTRODE PADS. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PATIENT. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720545 X SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION X SERIES NA 00847946006389

    Patients

    Seq Age Sex Outcome Treatment
    1