BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM XLD SPANISH

    MDR report key: 4142658 · Received September 26, 2014

    Report

    Report Number
    9615050-2014-05391
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 8, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K010924
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION FOUND THE DEVICE AC RECEPTACLE SHOWED EVIDENCE OF BURNED AND WITH TRACES OF FLUID SPILLAGE, FOR THIS REASON IT WAS IMPOSSIBLE TO CONNECT THE DEVICE ON AC, SO THE DEVICE WAS OPENED AND PERFORMED VISUAL INSPECTION OF POWER SUPPLY AND IT AND DID NOT OBSERVE ANY DAMAGED OR SPILLAGE ON IT. THE DEVICE WAS RETURNED WITHOUT THE AC POWER CORD. REPLACED AC RECEPTACLE FOR A GOOD ONE AND USED A NEW AC POWER CORD FOR A GOOD ONE TOO. (BUT NOT IN THE PRINTED WIRED ASSEMBLY'S). THE DEVICE PASSED THE ELECTRICAL SAFETY TEST. DURING THE TESTING THERE WAS NO ELECTRICAL SPARKING, SMOKE OR FLAMES OBSERVED. 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 DURING PREVENTATIVE MAINTENANCE TESTING AT THE USER FACILITY, THE AC CONNECTOR ON THE DEVICE WAS FOUND TO BE BURNED. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS OR DELAYS IN CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600769 PLUM XLD SPANISH 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA