BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ SINGLE CHANNEL

    MDR report key: 2152559 · Received June 27, 2011

    Report

    Report Number
    9615050-2011-00461
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    February 2, 2011
    Report Date
    February 2, 2011
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K041550
    Removal / Correction Number
    Z-1596-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED ON (B)(4) 2011. DURING TESTING CHARRING WAS FOUND ON THE NEUTRAL AND LINE VOLTAGE BLADES AND GROUND PRONG OF THE AC POWER CORD PLUG. THE DEVICE PASSED THE ELECTRICAL SAFETY TEST. THE CAUSE OF THE CHARRING ON THE AC POWER CORD PLUG COULD NOT BE DETERMINED. THE DEVICE HAS BEEN IDENTIFIED AS PART OF A PRODUCT RECALL. THE EVENT THAT IS BEING REPORTED WAS NOTED DURING VERIFICATION TESTING; THEREFORE, USER FACILITY EVENT CODES ARE NOT APPLICABLE IN THIS CASE. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    DURING VERIFICATION TESTING AT THE SERVICE CENTER, THE MALE END OF THE AC POWER CORD PLUG WAS FOUND TO BE CHARRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYMBIQ SINGLE CHANNEL 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA