BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMSTR AC ADPT 6FT CD

    MDR report key: 2152465 · Received June 27, 2011

    Report

    Report Number
    2921482-2011-00085
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    June 10, 2011
    Report Date
    June 10, 2011
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K060806
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS 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 SPARKS. THE DEVICE WAS CONNECTED TO A GEMSTAR PUMP AND WAS PLUGGED INTO THE AC POWER OUTLET. THE PUMP WAS DELIVERING AN UNSPECIFIED MEDICATION AT AN UNSPECIFIED RATE. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, SPARKS WERE NOTED FROM AN UNSPECIFIED LOCATION ON THE AC POWER ADAPTER. THE DEVICES WERE REPLACED AND THE THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GMSTR AC ADPT 6FT CD 80FRN FRN HOSPIRA, INC. NA 82787G1

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK GEMSTAR PUMP, LIST #13000, SN (B)(4)