BEUDAMED
    FDA Adverse Event Death Summary report: N

    COMPONENT MONITORING SYSTEM

    MDR report key: 302092 · Received October 26, 2000

    Report

    Report Number
    9610816-2000-00207
    Event Type
    Death
    Date Received
    October 26, 2000
    Date of Event
    October 26, 2000
    Manufacturer
    AGILENT TECHNOLOGIES DEUTSCHLAND GMBH
    Product Code
    DPS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE ATTENDING NURSE SUSPENDED THE ALARMS DURING PT CARE. THE NURSE WAS UNAWARE THAT THE ALARMS WERE CONFIGURED FOR INFINITE ALARM SUSPEND. THE PT'S RHYTHM CHANGED TO ASYSTOLE AND NO ALARM WAS GENERATED AS A RESULT OF THE BEDSIDE ALARM BEING SUSPENDED INDEFINITELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPONENT MONITORING SYSTEM CMS DPS AGILENT TECHNOLOGIES DEUTSCHLAND GMBH M1176A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death