BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUTORR PLUS MONITOR

    MDR report key: 3091804 · Received April 30, 2013

    Report

    Report Number
    2221819-2013-01061
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 30, 2013
    Manufacturer
    MINDRAY DS USA, INC.
    Product Code
    DXN
    PMA / PMN Number
    983575
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPANY REPRESENTATIVE EVALUATED THE UNIT AND REPLACED THE POWER SUPPLY. UNIT WAS TESTED TO FACTORY'S SPECIFICATIONS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE ACCUTORR PLUS MONITOR WAS NOT WORKING PROPERLY WHEN RAN ON BATTERY, WHICH MAY HAVE AFFECTED PRIMARY MONITORING. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187461 ACCUTORR PLUS MONITOR BLOOD PRESSURE MONITOR DXN MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1