BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ DUAL CHANNEL

    MDR report key: 2152453 · Received June 28, 2011

    Report

    Report Number
    9615050-2011-00464
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    May 19, 2011
    Report Date
    June 2, 2011
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K041550
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REC'D. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE RPTR UPON QUERY BY HOSPIRA.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A CHARRED AC POWER CORD. THE CUSTOMER CONTACT REPORTED THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPT FOR AN UNSPECIFIED REASON. NO TRACKING INFO WAS PROVIDED; SPECIFIC PT INFO, PUMP PROGRAMMING, OR EVENT DETAILS WERE NOT AVAILABLE. DURING TESTING AT THE USER FACILITY, THE DEVICE WAS CONNECTED TO AC POWER TO CHARGE THE DEVICE. AFTER AN UNSPECIFIED LENGTH OF TIME, THE CUSTOMER CONTACT INITIALLY INDICATED THE POWER CORD WAS BURNT; SUBSEQUENTLY, IT WAS REPORTED THE DEVICE WAS SMOKING AND HAD A BURNT SMELL. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS OR DELAYS IN 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 SYMBIQ DUAL CHANNEL 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA