BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM A + DRIVER NEW

    MDR report key: 3861054 · Received April 14, 2014

    Report

    Report Number
    9615050-2014-02673
    Event Type
    Malfunction
    Date Received
    April 14, 2014
    Date of Event
    February 26, 2014
    Report Date
    March 18, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K042081
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED. INVESTIGATION IS NOT COMPLETE. 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 AND CHARRING. THE DEVICE WAS RETURNED TO THE CENTRAL PROCESSING DEPT WITH A UNSIGNED NOTE THAT STATED, "THIS MACHINE SPARKS; PLUG IS BURNT." NO TRACKING INFO WAS PROVIDED; THEREFORE, SPECIFIC PT INFO, PUMP PROGRAMMING, OR EVENT DETAILS WERE NOT AVAILABLE. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS OR DELAYS IN CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. DURING TESTING AT THE USER FACILITY, IT WAS NOTED THAT THE FEMALE END OF THE AC POWER CORD WAS CHARRED. NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228154 PLUM A + DRIVER NEW 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK PLUM A+ SOFTWARE MODULE, LIST# 20791, SN (B)(4)