BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DASH 2500

    MDR report key: 2552131 · Received April 24, 2012

    Report

    Report Number
    9710602-2012-00001
    Event Type
    Malfunction
    Date Received
    April 24, 2012
    Date of Event
    March 27, 2012
    Report Date
    March 27, 2012
    Manufacturer
    GE MEDICAL SYSTEMS (CHINA) CO., LTD
    Product Code
    DXN
    PMA / PMN Number
    K090702
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WAS NO AUDIO FROM THE LOUDSPEAKER ON THE DASH 2500 PATIENT MONITOR. THE COMPLAINT INDICATES THAT THE DEVICE FAILED THE AUDIO TEST DUE TO DC2DC BOARD FAILURE. THERE WAS NO REPORTED PT INJURY ASSOCIATED WITH THIS EVENT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DASH 2500 PHYSIOLOGICAL PATIENT MONITOR DXN GE MEDICAL SYSTEMS (CHINA) CO., LTD UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1