BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUTORR PLUS II MONITOR

    MDR report key: 3091215 · Received April 30, 2013

    Report

    Report Number
    2221819-2013-00771
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    February 27, 2013
    Report Date
    April 30, 2013
    Manufacturer
    MINDRAY DS USA, INC.
    Product Code
    MHX
    PMA / PMN Number
    983575
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPANY REP EVALUATED THE UNIT AND REPLACED THE SRAMS. UNIT CALIBRATED AND SAFETY TESTED TO FACTORY SPECIFICATIONS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE ACCUTORR PLUS II MONITOR SHUTS DOWN, WHICH MAY HAVE RESULTED IN LOSS OF MONITORING. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188149 ACCUTORR PLUS II MONITOR PATIENT MONITOR MHX MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1