BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM XLM W/DATAPORT

    MDR report key: 2181025 · Received July 7, 2011

    Report

    Report Number
    9615050-2011-00481
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    May 4, 2011
    Report Date
    May 4, 2011
    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
    TW
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. 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 TESTING AT THE USER FACILITY, IT WAS NOTED THAT THE GROUND PRONG ON THE AC POWER CORD PLUG WAS LOOSE. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUM XLM W/DATAPORT 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA