BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUTORR PLUS

    MDR report key: 2980995 · Received January 29, 2013

    Report

    Report Number
    2221819-2013-00037
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Date of Event
    October 11, 2012
    Report Date
    January 30, 2013
    Manufacturer
    MINDRAY DS USA, INC
    Product Code
    MHX
    PMA / PMN Number
    983575
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP EVALUATED THE UNIT. CORRECTIONS INCLUDED REPLACEMENTS OF SRAM MEMORY AND FLASH MEMORY PROGRAMS IN THE CPU BOARD. THE SYSTEM WAS TESTED TO FACTORY'S SPECS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE ACCUTORR PLUS MONITOR SHUTS DOWN. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38719 ACCUTORR PLUS NONE MHX MINDRAY DS USA, INC

    Patients

    Seq Age Sex Outcome Treatment
    1