BEUDAMED
    FDA Adverse Event Death Summary report: N

    R SERIES DEFIBRILLATOR

    MDR report key: 6963076 · Received October 19, 2017

    Report

    Report Number
    1220908-2017-02566
    Event Type
    Death
    Date Received
    October 19, 2017
    Date of Event
    September 7, 2017
    Report Date
    September 28, 2017
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    DRT
    UDI-DI
    00847946017200
    PMA / PMN Number
    K060559
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO ZOLL MEDICAL CORPORATION FOR EVALUATION. FOLLOW-UP COMMUNICATION WITH THE CUSTOMER CONFIRMED THAT THE ONE-STEP PACING CABLE WAS NOT ATTACHED TO THE DEVICE DURING THE REPORTED EVENT. THE ONE-STEP ELECTRODE PADS WERE PROPERLY ATTACHED TO THE PATIENT. HOWEVER, AFTER THE EVENT, IT WAS OBSERVED THAT THE ONE-STEP PACING CABLE WAS NOT ATTACHED TO THE DEVICE, CAUSING THE CUSTOMER'S REPORT OF NO ECG SIGNAL. 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 PACE A (B)(6) OLD FEMALE PATIENT, THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED, HOWEVER IT WAS NOT A RESULT OF THE REPORTED ALLEGED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742737 R SERIES DEFIBRILLATOR DEFIBRILLATOR/PACEMAKER DRT ZOLL MEDICAL CORPORATION R SERIES NA 00847946017200

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR Death