BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARDIAC MONITOR

    MDR report key: 27187 · Received October 18, 1995

    Report

    Report Number
    MW1007360
    Event Type
    Death
    Date Received
    October 18, 1995
    Date of Event
    September 18, 1995
    Report Date
    October 2, 1995
    Manufacturer
    MEDICAL DATA ELECTRONICS
    Product Code
    DRT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE CARDIAC MONITOR WAS ON & ALARMS WERE SET. THE PT EXPERIENCED BRADYCARDIA THAT PROGRESSED TO ASYSTOLE. HOWEVER, THE BEDSIDE MONITOR & THE CENTRAL NURSING STATION MONITOR DID NOT ALARM. IT IS UNCLEAR WHY THE ALARM DID NOT SOUND EVEN THOUGH IT WAS SET, & IT IS UNCLEAR IF THE PT WOULD HAVE BEEN SUCCESSFULLY RESUSCITATED IF THE ALARM WOULD HAVE SOUNDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIAC MONITOR CARDIAC MONITOR DRT MEDICAL DATA ELECTRONICS 20100

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death