BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUTORR PLUS MONITOR

    MDR report key: 3091489 · Received April 30, 2013

    Report

    Report Number
    2221819-2013-00512
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    December 21, 2012
    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
    IA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    MINDRAY SVC REPS REPLACED THE SPO2 BOARD. UNIT CALIBRATED AND SAFETY TESTED TO FACTORY SPECIFICATIONS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN ISSUE WITH THE ACCUTORR PLUS MONITOR, WHICH MAY HAVE RESULTED IN A LOSS OF SPO2 MONITORING. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186408 ACCUTORR PLUS MONITOR PATIENT MONITOR DXN MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1