BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROCARE MONITOR B20

    MDR report key: 3817772 · Received April 1, 2014

    Report

    Report Number
    9710602-2014-00004
    Event Type
    Malfunction
    Date Received
    April 1, 2014
    Date of Event
    March 1, 2014
    Report Date
    March 4, 2014
    Manufacturer
    GE MEDICAL SYSTEMS (CHINA) CO., LTD.
    Product Code
    MHX
    PMA / PMN Number
    K122253
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    E-MAIL ADDRESS AND OCCUPATION OF REPORTER IS UNK. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THERE WAS WHITE SMOKE COMING FROM THE PROCARE MONITOR B20. THERE WAS NO PT INVOLVEMENT AS THE SMOKE WAS NOTICED PRIOR TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196201 PROCARE MONITOR B20 PHYSIOLOGICAL PATIENT MONITOR MHX GE MEDICAL SYSTEMS (CHINA) CO., LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1