BEUDAMED
    FDA Adverse Event Death Summary report: N

    R SERIES DEFIBRILLATOR

    MDR report key: 6087410 · Received November 8, 2016

    Report

    Report Number
    1220908-2016-02750
    Event Type
    Death
    Date Received
    November 8, 2016
    Date of Event
    October 18, 2016
    Report Date
    October 19, 2016
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    K060559
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE AND SUSPECT ELECTRODES WERE NOT RETURNED TO ZOLL MEDICAL CORPORATION FOR EVALUATION. INSTEAD, THE CUSTOMER RETURNED THE DEVICE ACTIVITY LOG FOR EVALUATION AND PROVIDED PICTURES LOCALIZED TO THE AREA IN QUESTION OF THE PATIENT. REVIEW OF THE DEVICE ACTIVITY LOG INDICATED DEFIBRILLATION OR PACING WERE NOT PERFORMED ON THE PATIENT. REVIEW OF PHOTOS OF THE REPORTED EVENT INDICATED A POSSIBLE SKIN REACTION TO THE ELECTRODE PADS. NO TREND IS ASSOCIATED WITH REPORTS OF THIS TYPE.

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE PRODUCT 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) FEMALE PATIENT, THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL VIA ELECTRODE PADS. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER SET OF ELECTRODE PADS TO CONTINUE MONITORING THE PATIENT AND PERFORMED CPR. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736592 R SERIES DEFIBRILLATOR DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION R SERIES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Death