BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM XLM INT ENGLISH

    MDR report key: 4002451 · Received July 9, 2014

    Report

    Report Number
    9615050-2014-04356
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 19, 2014
    Report Date
    June 19, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K010924
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION FOUND EVIDENCE OF SMOKE WITH BURN MARKS AND SIGNS OF MELTING AROUND THE AC RECEPTACLE. THIS WAS DUE TO A SHORT CIRCUIT CAUSED BY FLUID SPILLAGE AROUND THE AC RECEPTACLE. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THAT PRIOR TO PATIENT USE, THERE WAS ELECTRICAL SPARKING NOTED AT THE AC RECEPTACLE OF THE DEVICE WHILE OPERATING ON AC POWER. THERE WERE NO REPORTS OF ADVERSE PATIENT EVENTS OR DELAYS IN CRITICAL THERAPY WHILE THE DEVICE WAS IN CLINICAL USE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399048 PLUM XLM INT ENGLISH 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA