BEUDAMED
    FDA Adverse Event Death Summary report: N

    R SERIES DEFIBRILLATOR

    MDR report key: 7342261 · Received March 15, 2018

    Report

    Report Number
    1220908-2018-00664
    Event Type
    Death
    Date Received
    March 15, 2018
    Date of Event
    February 21, 2018
    Report Date
    February 22, 2018
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    DRT
    UDI-DI
    00847946017521
    PMA / PMN Number
    K060559
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO ZOLL MEDICAL CORPORATION FOR EVALUATION. INSTEAD, THE FULL DISCLOSURE LOG AND DEVICE ACTIVITY LOGS WERE RETURNED. REVIEW OF THE CLINICAL DATA DETERMINED THAT THE PACE PORTION OF THE ONE STEP COMPLETE PACING CABLE WAS NOT CONNECTED TO THE DEVICE'S ECG CONNECTOR CAUSING NO ECG SIGNAL TO BE DISPLAYED. THIS REPORT HAS BEEN ATTRIBUTED TO IMPROPER USE (SET UP) OF THE DEVICE BY THE END USER. 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 INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184297 R SERIES DEFIBRILLATOR DEFIBRILLATOR/PACEMAKER DRT ZOLL MEDICAL CORPORATION R SERIES NA 00847946017521

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death