BEUDAMED
    FDA Adverse Event Death Summary report: N

    ESCORT PRISM

    MDR report key: 361040 · Received November 16, 2001

    Report

    Report Number
    2022870-2001-00018
    Event Type
    Death
    Date Received
    November 16, 2001
    Date of Event
    October 11, 2001
    Report Date
    October 11, 2001
    Manufacturer
    MEDICAL DATA ELECTRONICS
    Product Code
    DRO
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WENT INTO AN ARRHYTHMIA WHILE BEING ATTENDED TO BY A "CRASH TEAM" OF CLINICIANS. ONE OF THE TEAM MEMBERS NOTICED THE MONITOR WAS NOT ALARMING (AUDIBLE ALARM).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51828 ESCORT PRISM PATIENT MONITOR DRO MEDICAL DATA ELECTRONICS 20403 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death