BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCLAIM ENCORE 2.25

    MDR report key: 1950151 · Received December 9, 2010

    Report

    Report Number
    2921482-2010-00971
    Event Type
    Malfunction
    Date Received
    December 9, 2010
    Date of Event
    October 3, 2010
    Report Date
    November 17, 2010
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K011096
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFO KNOW BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THAT DURING TESTING BETWEEN PT USE AT THE USER FACILITY, SPARKS WERE NOTED INSIDE THE CLEAR PLUG ON THE MALE END OF THE AC POWER CORD AFTER THE AC POWER CORD WAS PLUGGED INTO THE AC POWER OUTLET. IT WAS REPORTED THAT THE SPARKS WERE NOTED WHEN THE AC POWER CORD WAS TWISTED OR PULLED. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCLAIM ENCORE 2.25 80FRN FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA