BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM 1.6 WITH DATAPO

    MDR report key: 2152217 · Received June 23, 2011

    Report

    Report Number
    9615050-2011-00448
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Date of Event
    May 25, 2011
    Report Date
    May 25, 2011
    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
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER PERFORMED TESTING AND INVESTIGATION AT THE USER FACILITY. A VISUAL INSPECTION FOUND THAT THE GROUND PRONG ON THE AC POWER CORD WAS BROKEN. THE PROBABLE CAUSE FOR THE BENT BLADE ON THE AC POWER CORD IS USE IN THE CUSTOMER ENVIRONMENT. IF THE AC POWER CORD IS ATTEMPTED TO BE REMOVED FROM AN OUTLET BY PULLING AT ANGLE, IT IS POSSIBLE TO DAMAGE THE AC POWER CORD BLADE. 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 THAT DURING TESTING AT THE USER FACILITY, IT WAS NOTED THAT THE GROUND PRONG ON THE AC POWER CORD PLUG WAS BROKEN. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS OR DELAYS IN 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 PLUM 1.6 WITH DATAPO 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA