BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STATVIEW

    MDR report key: 432720 · Received December 10, 2002

    Report

    Report Number
    2124823-2002-00019
    Event Type
    Malfunction
    Date Received
    December 10, 2002
    Date of Event
    August 11, 2002
    Report Date
    December 10, 2002
    Manufacturer
    GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN
    Product Code
    MSX
    Removal / Correction Number
    2124823-12/09/02-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE NURSING STAFF NOTICED THAT AN "ASYSTOLE" CALL FROM THE ARRHYTMIA MONITORING SYSTEM WAS NOT RECEIVED BY THE STATVIEW PAGER. OTHER ALARMS IMMEDIATELY PRIOR TO THIS, INCLUDING "BRADY" AND "LO HR" WERE RECEIVED BY THE PAGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STATVIEW ALARM NOTIFICATION SYSTEM MSX GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN STATVIEW NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN