BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM MONITOR

    MDR report key: 3091653 · Received April 30, 2013

    Report

    Report Number
    2221819-2013-00670
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    November 5, 2012
    Report Date
    April 30, 2013
    Manufacturer
    MINDRAY DS USA, INC
    Product Code
    MHX
    PMA / PMN Number
    062098
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    MINDRAY SERVICE REPS REPLACED THE MONITORS MAIN BOARD. PERFORMED ALL FUNCTIONAL AND SAFETY CHECKS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A FAILED DISPLAY ON THE SPECTRUM MONITOR, WHICH MAY HAVE RESULTED IN A LOSS OF PRIMARY MONITORING. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186809 SPECTRUM MONITOR PATIENT MONITOR MHX MINDRAY DS USA, INC

    Patients

    Seq Age Sex Outcome Treatment
    1