BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACELABS ULTRAVIEW 1050 MONITOR

    MDR report key: 2043558 · Received March 25, 2011

    Report

    Report Number
    3023361-2011-00009
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Date of Event
    February 17, 2011
    Report Date
    March 25, 2011
    Manufacturer
    SPACELABS HEALTHCARE
    Product Code
    DSI
    PMA / PMN Number
    K972282
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, WE ARE ATTEMPTING TO REPRODUCE THE REPORTED SYMPTOMS AND IDENTIFY THE ROOT CAUSE. NO ONE HAS BEEN INJURED AS A RESULT OF THIS CONDITION. WE WILL PROVIDE A SUPPLEMENTAL REPORT ONCE OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    A HOSPITAL REPORTED A RECENTLY REPAIRED MONITOR RANDOMLY SHUTTING OFF AS A PATIENT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPACELABS ULTRAVIEW 1050 MONITOR MULTIPARAMETER PATIENT MONITOR DSI SPACELABS HEALTHCARE 90369

    Patients

    Seq Age Sex Outcome Treatment
    1