BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER SUPPLY UNIT, SL

    MDR report key: 1663338 · Received April 7, 2010

    Report

    Report Number
    2031963-2010-00063
    Event Type
    Malfunction
    Date Received
    April 7, 2010
    Date of Event
    March 11, 2010
    Report Date
    April 6, 2010
    Manufacturer
    STRYKER COMMUNICATIONS
    Product Code
    FSY
    PMA / PMN Number
    K031068
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: STRYKER COMMUNICATIONS MADE SEVERAL UNSUCCESSFUL ATTEMPTS TO CONTACT THE HOSPITAL AND/OR MEDICAL STAFF TO GATHER ADD'L INFO REGARDING THE REPORTED EVENT. A HYPOTHESIS HAS BEEN DRAWN BASED ON THE ENGINEER'S EXPERIENCE WITH THE PRODUCT AND THE INSUFFICIENT DETAILS OF THE EVENT. ALTHOUGH BOTH LIGHTS WENT OUT FOR A SHORT PERIOD OF TIME, THE COMPLAINT STATES THAT THE LIGHTS SHORTLY CAME BACK ON AND WERE FULLY FUNCTIONAL. OUR RECORDS SHOW THAT STRYKER COMMUNICATION HAS HAD INSTALLED A UPS SYSTEM AT THIS HOSPITAL DUE TO PREVIOUS REPORTS RELATED TO POWER SURGE ISSUES AT THIS SITE. THE UPS SYSTEM KICKED IN AND THE LIGHTS WERE ABLE TO REBOOT WITHIN A SHORT AMOUNT OF TIME. THERE APPEARS TO BE A POWER ISSUE (ELECTRICAL SURGE) WITHIN THAT AREA OF THE HOSPITAL; HOWEVER, STRYKER COMMUNICATION IS UNABLE TO DETERMINE EXACT CAUSE OF THE FAILURE. THE LIGHTS WERE TESTED AND BOTH FUNCTIONED AS INTENDED. EVERY REASONABLE ATTEMPT HAS BEEN MADE TO CONTACT THE HOSPITAL/MEDICAL STAFF TO OBTAIN MORE INFO SURROUNDING THIS EVENT. NO OTHER INFO HAS BEEN RECEIVED BY STRYKER COMMUNICATION AT THIS TIME.

    Description of Event or Problem · 1

    DURING THE SURGERY, TWO VISUM 600 HALOGEN LIGHTS TURNED OFF BUT SHORTLY CAME BACK ON. NO FURTHER INFO PROVIDED TO THE MFR REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWER SUPPLY UNIT, SL FSY STRYKER COMMUNICATIONS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI