BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVICE, CCU, HIGH DEF, 560P, 2NDGEN

    MDR report key: 5641937 · Received May 9, 2016

    Report

    Report Number
    1643264-2016-00064
    Event Type
    Malfunction
    Date Received
    May 9, 2016
    Date of Event
    April 21, 2016
    Report Date
    April 21, 2016
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GCJ
    PMA / PMN Number
    K070266
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL INSPECTION WAS PERFORMED ON THE PRODUCT AND NO DAMAGE WAS OBSERVED. COMPLAINT OF OVERHEATING ERROR COULD NOT BE REPRODUCED. PRODUCT PASSED FUNCTIONAL TESTING INCLUDING POWER CYCLING DURING 48 HOUR BURN-IN INSIDE OF TEST TOWER. CONTROL UNIT WAS TESTED AT DIFFERENT POWER INPUT VOLTAGE LEVELS RANGING FROM 90 TO 220 VOLTS. NO OVERHEATING OR POWER LOSS OCCURRED DURING 48 HOUR TESTING. ALL LIVE VIDEO OUTPUTS (COMPOSITE, S-VIDEO, HD-SDI, ETC...) NORMAL. ALL FUNCTIONS PERFORM AS EXPECTED. AFTER THE EVALUATION THE ROOT CAUSE FOR THE REPORTED ISSUE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    NO EVALUATION CONDUCTED TO DATE, AWAITING RECEIPT OF DEVICE. (B)(4).

    Additional Manufacturer Narrative · 1

    PMA/510(K)NUMBER: K070266.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE PRESENTED AN OVERHEATING ERROR AND WAS HOT TO THE TOUCH. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295299 SERVICE, CCU, HIGH DEF, 560P, 2NDGEN LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1