BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DPM 6/7 MONITOR

    MDR report key: 3091435 · Received April 30, 2013

    Report

    Report Number
    2221819-2013-00362
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    August 24, 2012
    Report Date
    April 30, 2013
    Manufacturer
    MINDRAY DS USA, INC.
    Product Code
    MHX
    PMA / PMN Number
    092449
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY SERVICE REP REPAIRED THE SOLDER ON THE CONNECTORS. CALIBRATED AND SAFETY TESTED UNIT TO FACTORY SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE MPM MODULE ON THE DPM 6/7 MONITOR PROVIDED INCORRECT ECG READINGS. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186614 DPM 6/7 MONITOR PATIENT MONITOR MHX MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1