BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DPM CENTRAL STATION

    MDR report key: 3091641 · Received April 30, 2013

    Report

    Report Number
    2221819-2013-00637
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    November 5, 2012
    Report Date
    April 30, 2012
    Manufacturer
    MINDRAY DS USA, INC.
    Product Code
    MHX
    PMA / PMN Number
    080192
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    MINDRAY SERVICE REPRESENTATIVES ADVISED THE CUSTOMER TO CHECK THE CABLES AND REBOOT THE SYSTEM WHICH RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN ISSUE WITH THE DPM TELEPACK WHICH MAY HAVE RESULTED IN A LOSS OF AMBULATORY TELEMETRY MONITORING. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186818 DPM CENTRAL STATION CENTRAL MONITORING STATION MHX MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1