BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLMA DVC V11.51 1 N

    MDR report key: 1944211 · Received December 6, 2010

    Report

    Report Number
    2921482-2010-00952
    Event Type
    Malfunction
    Date Received
    December 6, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 30, 2010
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K070398
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THE AC POWER CORD WAS CHARRED AND MELTED. THE DEVICE WAS PROGRAMMED TO DELIVER AN UNSPECIFIED HYDRATION FLUID AND THE DELIVERY WAS STARTED. NO SPECIFIC PROGRAMMING PARAMETERS WERE PROVIDED. AFTER AN UNSPECIFIED LENGTH OF TIME, THE NURSE WALKED PAST THE PATIENT'S ROOM AND NOTED A BURNING SMELL. THE NURSE ENTERED THE PATIENT'S ROOM AND NOTED CHARRING ON THE WALL AND FOUND THE MALE END OF THE AC POWER CORD WAS CHARRED AND MELTED. THE ENGINEERING DEPARTMENT WAS NOTIFIED. THE DEVICE WAS UNPLUGGED FROM THE AC POWER OUTLET AND THE WALL OUTLET COVER WAS REPLACED. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. THERAPY WAS RESUMED USING A REPLACEMENT DEVICE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO DELAY CRITICAL TO THIS PATIENT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLMA DVC V11.51 1 N 80FRN FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 PLUM A+ SOFTWARE MODULE| LIST #12097, (B)(4)