BEUDAMED
    FDA Adverse Event Death Summary report: N

    ASSY,MAIH, 3.0 DIA, W/SWITCH

    MDR report key: 5194716 · Received November 2, 2015

    Report

    Report Number
    1220908-2015-02844
    Event Type
    Death
    Date Received
    November 2, 2015
    Date of Event
    July 9, 2015
    Report Date
    October 14, 2015
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    LDD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS INADVERTENTLY SUBMITTED AS A DUPLICATE. THE REPORTED EVENT WAS ORIGINALLY REPORTED UNDER MEDWATCH 1220908-2015-01952. PLEASE REFER TO MEDWATCH REPORT 1220908-2015-01952 FOR THE INVESTIGATION RESULTS. THIS IS BEING CLOSED AS A DUPLICATE REPORT.

    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 FEMALE PATIENT (AGE UNKNOWN), AFTER SUCCESSFULLY DISCHARGING THREE SHOCKS TO THE PATIENT, THE ASSOCIATED DEVICE FAILED TO DISCHARGE USING THESE INTERNAL HANDLES. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED, HOWEVER IT WAS NOT A RESULT OF THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726834 ASSY,MAIH, 3.0 DIA, W/SWITCH INTERNAL PADDLE LDD ZOLL MEDICAL CORPORATION 1011-0139-04 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death