BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X SERIES

    MDR report key: 11516998 · Received March 18, 2021

    Report

    Report Number
    1220908-2021-00758
    Event Type
    Malfunction
    Date Received
    March 18, 2021
    Date of Event
    February 23, 2021
    Report Date
    February 25, 2021
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    UDI-DI
    00847946005979
    PMA / PMN Number
    K112432/P160
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED TO ZOLL MEDICAL CORPORATION FOR EVALUATION. INSTEAD, THE DATA FILE OF THE CUSTOMER'S REPORT WAS PROVIDED. REVIEW OF THE DATA FILE SHOWS THAT A SIGNAL FROM THE ELECTRODES WAS IDENTIFIED AND CAPABLE OF DISPLAYING WHEN ATTACHED. HOWEVER, THE END USER CHANGED THE LEAD VIEW TO LEAD I. HAD THE LEAD VIEW BEEN CHANGED BACK TO PADS, THE DEVICE WOULD HAVE DISPLAYED THE ECG SIGNAL. THERE IS NO EVIDENCE OF A DEVICE MALFUNCTION. 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 (B)(6) YEAR OLD MALE PATIENT, THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL VIA ELECTRODE PADS. 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
    415642 X SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION X SERIES NA 00847946005979

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR