BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE CARESCAPE CENTRAL STATION

    MDR report key: 5939012 · Received September 1, 2016

    Report

    Report Number
    MW5064627
    Event Type
    Malfunction
    Date Received
    September 1, 2016
    Date of Event
    August 23, 2016
    Report Date
    September 1, 2016
    Manufacturer
    GE
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT WENT INTO ASYSTOLE AND IT TOOK 9 SECONDS FOR IT TO ALARM. B450 ECN IS (B)(4) TELE BOX ECN IS (B)(4) CARESCAPE CENTRAL STATION WAS LV-E ECN IS (B)(4) TTX ID OF TELE BOX IS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575177 GE CARESCAPE CENTRAL STATION CARESCAPE CENTRAL STATION MHX GE B450

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR