BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DINAMAP PROCARE 300

    MDR report key: 2922036 · Received January 15, 2013

    Report

    Report Number
    3008729547-2013-00001
    Event Type
    Malfunction
    Date Received
    January 15, 2013
    Date of Event
    December 18, 2012
    Report Date
    December 18, 2012
    Manufacturer
    CRITIKON DE MEXICO S. DE R.L. DE C.V.
    Product Code
    MWI
    PMA / PMN Number
    K014255
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OCCUPATION OF REPORTER IS UNKNOWN. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A BURNING SMELL COMING FROM THE UNIT. THE GE FIELD ENGINEER FOUND THE SMELL WAS DUE TO A DAMAGED POWER CABLE HEAD WHICH HAD MELTED AND BURNED. THERE WAS NO REPORTED PT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22560 DINAMAP PROCARE 300 PHYSIOLOGICAL PATIENT MONITOR MWI CRITIKON DE MEXICO S. DE R.L. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1