BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM XLM W/DATAPORT

    MDR report key: 3872459 · Received April 18, 2014

    Report

    Report Number
    9615050-2014-02776
    Event Type
    Malfunction
    Date Received
    April 18, 2014
    Date of Event
    January 1, 2012
    Report Date
    February 8, 2012
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K010924
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL TESTING AT THE USER FACILITY OCCURRED ON (B)(4) 2012. INITIALLY, THE AC POWER CORD WAS TO BE RETURNED TO THE SERVICE CENTER FOR FURTHER TESTING; HOWEVER, THE AC POWER CORD WAS NOT RECEIVED. HOSPIRA COULD NOT COMPLETE THE TESTING AND INVESTIGATION ON THE POWER CORD ASSOCIATED WITH THE REPORTED EVENT. THIS REPORT IS BEING MADE AS PART OF A RETROSPECTIVE REVIEW. NO FURTHER TESTING OR INVESTIGATION WILL BE PERFORMED. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    DURING TESTING AT THE USER FACILITY, IT WAS NOTED THAT THE DEVICE AC POWER CORD GROUND PRONG WAS BROKEN. THE DEVICE WAS BROUGHT TO THE BIOMEDICAL DEPARTMENT FOR AN UNSPECIFIED REASON. NO TRACKING INFORMATION WAS PROVIDED; THEREFORE, SPECIFIC PATIENT INFORMATION, DEVICE PROGRAMMING OR EVENT DETAILS WERE NOT AVAILABLE. THERE WERE NO REPORTED ADVERSE PATIENT EVENTS OR DELAYS IN CRITICAL THERAPY WHILE THE DEVICE WAS IN CLINICAL USE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238072 PLUM XLM W/DATAPORT 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK