BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X SERIES

    MDR report key: 6182634 · Received December 16, 2016

    Report

    Report Number
    1220908-2016-03112
    Event Type
    Malfunction
    Date Received
    December 16, 2016
    Date of Event
    November 28, 2016
    Report Date
    November 28, 2016
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    K112432
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS RECEIVED THE PRODUCT AND WILL BE PROVIDING A FOLLOW-UP REPORT WHEN OUR INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION EVALUATED THE DEVICE AND THE DEVICE PERFORMED TO SPECIFICATION. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. REVIEW OF THE CLINICAL DATA DID SHOW INSTANCES OF ELECTRODE PAD NOT CONNECTED FOR THE FIRST 34 MINUTES OF THE CASE. EVENTUALLY, THE DATA SHOWED THE ELECTRODE PADS BEING CONNECTED; HOWEVER, THE PADS VIEW WASN'T SELECTED BY THE USER TO DISPLAY THE ECG SIGNAL. THE ELECTRODE PADS WERE NOT RETURNED TO ZOLL MEDICAL CORPORATION AS PART OF THIS INVESTIGATION. IT'S IMPORTANT TO NOTE THE CUSTOMER COMMUNICATED THAT THE SAME SET OF ELECTRODE PADS WERE ABLE TO BE USED WITH ANOTHER DEVICE. THIS REPORT IS BEING CLOSED AS ECG WAS AVAILABLE TO THE END USER, BUT THE LEAD WAS NOT SELECTED. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    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 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
    831800 X SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION X SERIES N/A

    Patients

    Seq Age Sex Outcome Treatment
    1