BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM 1.6 W/DATAPORT

    MDR report key: 2191064 · Received July 25, 2011

    Report

    Report Number
    9615050-2011-00559
    Event Type
    Malfunction
    Date Received
    July 25, 2011
    Date of Event
    January 1, 2011
    Report Date
    June 30, 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
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL TESTING OF THE DEVICE WAS CONDUCTED AT THE USER FACILITY ON (B)(4) 2011 BY THE HOSPIRA FIELD SERVICE ENGINEER. THE POWER CORD HAS BEEN RECEIVED. INVESTIGATION IS NOT COMPLETE. 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 THE GROUND PRONG ON THE AC POWER CORD PLUG WAS BROKEN. THE DEVICE WAS RETURNED TO THE BIOMEDICAL ENGINEERING DEPT WITH EXTENSIVE PHYSICAL DAMAGE. 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 PRONG ON THE AC POWER CORD PLUG WAS BROKEN OFF. 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 1.6 W/DATAPORT 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK