BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRISM SE

    MDR report key: 348378 · Received August 20, 2001

    Report

    Report Number
    2022870-2001-00013
    Event Type
    Death
    Date Received
    August 20, 2001
    Report Date
    August 16, 2001
    Manufacturer
    MEDICAL DATA ELECTRONICS
    Product Code
    DRT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT INCIDENT WHILE CONNECTED TO CO'S MONITOR. INFORMED THAT ON DUTY NURSE TURNED OFF ALARM AT BEDSIDE. PT ENTERED BRADY CARDIA AND THE ALARM DID NOT SOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38161 PRISM SE PORTABLE PATIENT MONITOR DRT MEDICAL DATA ELECTRONICS 20413 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death