BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM 1.6 W/DATAPORT

    MDR report key: 2971109 · Received February 1, 2013

    Report

    Report Number
    9615050-2013-00172
    Event Type
    Malfunction
    Date Received
    February 1, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 14, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K911401
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED ON (B)(4) 2013. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    DURING VERIFICATION TESTING AT THE SERVICE CENTER, IT WAS NOTED THE OUTER INSULATION OF THE AC POWER CORD HAD SEPARATED FROM THE FEMALE END OF THE AC POWER CORD AND THE INTERNAL INSULATION OF THE GREEN WIRE WAS BROKEN WITH AN EXPOSED BROKEN WIRE. THE WHITE WIRE BLADE WAS ALSO FOUND TO BE BENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45311 PLUM 1.6 W/DATAPORT 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA