BEUDAMED
    FDA Adverse Event Death Summary report: N

    MDE ESCORT

    MDR report key: 360799 · Received November 9, 2001

    Report

    Report Number
    2022870-2001-00017
    Event Type
    Death
    Date Received
    November 9, 2001
    Date of Event
    October 18, 2001
    Report Date
    October 19, 2001
    Manufacturer
    MEDICAL DATA ELECTRONICS
    Product Code
    LDD
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    AS PER THE CUSTOMER'S (USER FACILITY) COMPLAINT, THE DEFIBRILLATOR CHARGED AND DISCHARGED BUT THERE WAS NO OUTPUT THROUGH THE PADDLES. THE PATIENT DID GET DEFIBRILLATED BY A DIFFERENT (SECOND) WORKING DEFIBRILLATOR, BUT STILL EXPIRED. THE BIO-MED TESTED THE UNIT IN THE SHOP, AND FOUND THAT THE MALFUNCTION WAS REPEATABLE. THE CLINICIAN PRESENT AT THE TIME OF THE EVENT DESCRIBED THE SAME SEQUENCE OF EVENTS. THE CLINICIAN WAS ASKED IF THEY FELT THAT THE MDE EQUIPMENT MALFUNCTION CONTRIBUTED TO THE PATIENT DEATH TO WHICH THE CLINICIAN REPLIED "NO, NOT AT ALL". THE CLINICIAN STATED THAT A SECOND WORKING DEFIBRILLATOR WAS USED AND THE PATIENT OUTCOME DID NOT CHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50400 MDE ESCORT DEFIBRILLATOR LDD MEDICAL DATA ELECTRONICS 20202 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other