BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUTORR PLUS

    MDR report key: 2980729 · Received January 29, 2013

    Report

    Report Number
    2221819-2013-00010
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Date of Event
    August 28, 2012
    Report Date
    January 30, 2013
    Manufacturer
    MINDRAY DS USA, INC.
    Product Code
    DXN
    PMA / PMN Number
    983575
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPLACED THE POWER SUPPLY. THE UNIT WAS TESTED TO FACTORY'S SPECIFICATIONS. IT FUNCTIONED NORMALLY AND WAS RETURNED TO USE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE POWER SUPPLY IN THE DPM CENTRAL STATION BURNED. NO DETAILS TO HOW THE POWER SUPPLY BURNED WAS REPORTED. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40034 ACCUTORR PLUS NONE DXN MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1