BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLM A+3 MEDNET WRLSS

    MDR report key: 1873439 · Received September 20, 2010

    Report

    Report Number
    2921482-2010-00718
    Event Type
    Malfunction
    Date Received
    September 20, 2010
    Date of Event
    August 4, 2010
    Report Date
    August 28, 2010
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K042081
    Removal / Correction Number
    Z-0011-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. AS INDICATED, THIS DEVICE WAS IDENTIFIED AS PART OF THE CUSTOMER NOTIFICATION DATED AUGUST 19, 2009. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED SMOKE AND FLAMES NEAR THE FEMALE END OF THE AC POWER CORD. THE DEVICE WAS PLUGGED INTO THE AC POWER OUTLET IN AN EMPTY PT ROOM. AFTER AN UNSPECIFIED LENGTH OF TIME, IT WAS REPORTED THAT THE NURSE SMELLED SMOKE AND ENTERED THE ROOM. AT THIS TIME, THE NURSE NOTED FLAMES COMING OUT OF THE BACK OF THE DEVICE NEAR THE FEMALE END OF THE AC POWER CORD. THE NURSE UNPLUGGED THE DEVICE FROM THE AC OUTLET AND COVERED THE PUMP WITH A WET TOWEL TO EXTINGUISH THE FLAMES. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. DURING A VISUAL INSPECTION AT THE USER FACILITY, IT WAS NOTED THAT THE FEMALE END OF THE AC POWER CORD WAS BURNED AND THE BACK OF THE DEVICE WAS CHARRED. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE NURSE. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLM A+3 MEDNET WRLSS 80FRN FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1