BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PKG SPI2 HI RES PIP DVI

    MDR report key: 2181119 · Received July 8, 2011

    Report

    Report Number
    2031963-2011-00060
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    May 31, 2011
    Report Date
    June 1, 2011
    Manufacturer
    STRYKER COMMUNICATIONS
    Product Code
    GCJ
    PMA / PMN Number
    K033132
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO REPORT OF PT INVOLVEMENT THUS NO PT DATA EXISTS. THIS PRODUCT HAS NO EXPIRATION DATE. THE ACTUAL DEVICE WAS EVALUATED ON SITE AND REPLACED AND THE DEFECTIVE PRODUCT WAS RETURNED TO MFR FOR FURTHER INVESTIGATION. THE DEVICE MANUFACTURE DATE WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. EVAL SUMMARY: IT WAS REPORTED THAT THE SPI 2 WOULD NOT ROUTE ANY SOURCES TO ANY MONITORS. THE UNIT WAS REBOOTED MULTIPLE TIMES BUT IT STILL WOULD NOT FUNCTION. IT WAS FURTHER REPORTED THAT ALL THE MONITORS DISPLAYED NO SIGNAL. THE SWITCHPOINT INFINITY (SPI) ALLOWS DIRECT CONTROL OF ROOM EQUIPMENT, AUDIO/VIDEO EQUIPMENT, AND INDIRECT CONTROL, THROUGH THE STRYKER ENDOSCOPY SIDNE SYSTEM, OF SURGICAL EQUIPMENT IN THE OPERATING ROOM. THE SPI IS ALSO AN INTEGRATED VOICE, VIDEO AND DATA ROUTER AND TELECONFERENCING INTERFACE FOR THE OPERATING ROOM. PRELIMINARY TROUBLESHOOTING REVEALED THAT NONE OF THE VIDEO BOARDS WERE BEING RECOGNIZED ON THE HARDWARE. DURING ON-SITE SERVICING, THE FIELD SERVICE TECH NOTICED THERE WAS AN ODOR OF SMOKE OR CHARRED BOARD. NO ONE WITNESSED ANY EVIDENCE OF SMOKE OR BURNING, HOWEVER, A THERMAL EVENT APPEARS TO HAVE TAKEN PLACE. THE UNIT WAS REPLACED AND THE DEFECTIVE UNIT HAS BEEN RETURNED TO THE MFR FOR FURTHER INVESTIGATION. AT THE TIME OF THIS REPORT, THE ROOT CAUSE IS STILL UNDER INVESTIGATION. THERE WAS REPORT OF PT INVOLVEMENT OR ADVERSE CONSEQUENCES. THIS IS NOT A SINGLE USE DEVICE.

    Description of Event or Problem · 1

    (B)(4). (B)(6) CALLED IN BY (B)(6). OPERATING ROOM 4, SPI 2 WILL NOT ROUTE ANY SOURCES TO ANY MONITORS. REBOOTED MULTIPLE TIMES. SPI WILL BOOT TO INFINITY GUI BUT WILL NOT FUNCTION. ALL MONITORS DISPLAY NO SIGNAL. FOUND BEFORE CASES. ROOM HAS BEEN SHUT DOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PKG SPI2 HI RES PIP DVI GCJ STRYKER COMMUNICATIONS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK