BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITY SWITCH POINT 2

    MDR report key: 2135147 · Received June 15, 2011

    Report

    Report Number
    MW5021022
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Date of Event
    March 8, 2011
    Report Date
    June 15, 2011
    Manufacturer
    STRYKER COMMUNICATIONS
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    ELECTRONIC COMPONENTS ON VIDEO CIRCUIT CARD IN COMPUTER SECTION OF STRYKER COMMUNICATIONS INFINITY SWITCH POINT 2, SERIAL NUMBER (B)(4), OVERHEATED CAUSING THE SYSTEM TO FAIL AND SMOKE. OPERATING ROOM STAFF SMELLED AND SAW SMOKE COMING FROM DEVICE AND ACTIVATED THE FIRE ALARM. THE UNIT DID NOT START A FIRE. THE SMELL AND SMOKE CAME FROM THE COMPONENTS OVERHEATING THE VIDEO CARD. THE UNIT WAS TAKEN OUT OF SERVICE AND REPLACED WITH A NEW ONE BY STRYKER. STRYKER COMMUNICATIONS REMOVED THE UNIT FROM THE OPERATING ROOM AND SENT IT BACK TO MFR TO EXAMINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFINITY SWITCH POINT 2 NONE GCJ STRYKER COMMUNICATIONS INFINITY 2

    Patients

    Seq Age Sex Outcome Treatment
    1