BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X SERIES

    MDR report key: 6581448 · Received May 22, 2017

    Report

    Report Number
    1220908-2017-01149
    Event Type
    Malfunction
    Date Received
    May 22, 2017
    Date of Event
    April 26, 2017
    Report Date
    May 2, 2017
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    DRT
    UDI-DI
    00847946005979
    PMA / PMN Number
    K112432
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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

    THE DEVICE WAS RETURNED TO ZOLL MEDICAL CORPORATION; THE REPORTED MALFUNCTION WAS OBSERVED DURING REVIEW OF THE DEVICE'S ACTIVITY LOG. THE DEVICE WAS PUT THROUGH EXTENSIVE TESTING WITHOUT DUPLICATING THE REPORTED MALFUNCTION. THE DEVICE'S MONITOR BOARD WAS REPLACED AS A PRECAUTION. THE DEVICE SUCCESSFULLY PASSED THE FINAL TEST PROCEDURE, WAS RECERTIFIED, AND RETURNED TO THE CUSTOMER. ANALYSIS FOR 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 DISPLAYED AN"ECG DISABLED" MESSAGE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION. PLEASE REFERENCE MEDWATCH REPORT 1220908-2017-01148 FOR A SIMILAR EVENT REPORTED FROM THE SAME CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364359 X SERIES DEFIBRILLATOR/PACEMAKER DRT ZOLL MEDICAL CORPORATION X SERIES NA 00847946005979

    Patients

    Seq Age Sex Outcome Treatment
    1