BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANAROMA CENTRAL STATION

    MDR report key: 3091486 · Received April 30, 2013

    Report

    Report Number
    2221819-2013-00531
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    December 26, 2012
    Report Date
    April 30, 2013
    Manufacturer
    MINDRAY DS USA, INC.
    Product Code
    MHX
    PMA / PMN Number
    031760
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    MINDRAY SVC REPS ASSISTED THE CUSTOMER IN RESETTING THE SYSTEM. TESTED, CALIBRATED AND SAFETY CHECKED UNIT TO FACTORY SPECIFICATIONS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE PANORAMA CENTRAL STATION DISPLAYED AN ERROR MESSAGE 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
    186407 PANAROMA CENTRAL STATION PATIENT MONITORING STATION MHX MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1