BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM XLM W/MODIFD B

    MDR report key: 1931701 · Received November 22, 2010

    Report

    Report Number
    2921482-2010-00918
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    November 3, 2010
    Report Date
    November 3, 2010
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K010924
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL TESTING OF THE DEVICE WAS CONDUCTED AT THE USER FACILITY OF (B)(4) 2010 BY THE HOSPIRA FIELD SERVICE ENGINEER. THE POWER CORD IS EXPECTED TO BE RETURNED FOR FURTHER TESTING. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE RPTR UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THAT THE GROUND PIN ON THE AC POWER CORD PLUG WAS BENT. THE DEVICE WAS RETURNED TO THE BIOMEDICAL ENGINEERING DEPARTMENT WITH AN UNSIGNED NOTE THE STATED, "UNIT READS ERROR." NO TRACKING INFO WAS PROVIDED; THEREFORE, SPECIFIC PT INFO, PUMP PROGRAMMING, OR EVENT DETAILS WERE NOT AVAILABLE. DURING TESTING AT THE USER FACILITY, IT WAS NOTED THAT THE GROUND PIN ON THE AC POWER CORD PLUG WAS BENT. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUM XLM W/MODIFD B 80FRN FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK