BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM XLD SPANISH

    MDR report key: 3770826 · Received February 18, 2014

    Report

    Report Number
    9615050-2014-01263
    Event Type
    Malfunction
    Date Received
    February 18, 2014
    Date of Event
    January 12, 2014
    Report Date
    January 20, 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
    AR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION FOUND THE DEVICE AC RECEPTACLE WAS CHARRED AND BURNED. ADDITIONALLY DURING TESTING, IT WAS FOUND THAT THE PINS IN THE AC RECEPTACLE BETWEEN THE WHITE WIRE AND BLACK WIRE WERE FOUND ELECTRICALLY OPENED. THE DEVICE WAS RECEIVED WITHOUT THE AC POWER CORD. THE PROBABLE CAUSE COULD NOT BE DETERMINED. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED SPARKS. THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPARTMENT FOR A REPORT OF, "MADE SPARKS IN THE AC RECEPTACLE ON (B)(6), 2004". NO TRACKING INFO WAS PROVIDED; THEREFORE, SPECIFIC PT INFO, DEVICE PROGRAMMING, OR EVENT DETAILS WERE NOT AVAILABLE. THERE WERE NO REPORTS OF ANY ADVERSE EVENTS OR DELAYS IN CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101786 PLUM XLD SPANISH 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK