BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITY HIGH RES

    MDR report key: 2150388 · Received June 8, 2011

    Report

    Report Number
    2031963-2011-00044
    Event Type
    Malfunction
    Date Received
    June 8, 2011
    Date of Event
    May 11, 2011
    Report Date
    June 8, 2011
    Manufacturer
    STRYKER COMMUNICATIONS
    Product Code
    GCJ
    PMA / PMN Number
    K033132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO REPORT OF SPECIFIC PATIENT IMPACT, AND THUS NO PATIENT INFORMATION AVAILABLE. THERE IS NO EXPIRATION DATE FOR THIS PRODUCT. THE SERIAL NUMBER IS UNKNOWN SO THE DEVICE MANUFACTURE DATE IS UNKNOWN. DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER AT THE TIME OF THIS REPORT. EVALUATION SUMMARY: IT WAS REPORTED THAT BOTH MONITORS IN THE ROOM ARE UNABLE TO RECEIVE ANY SIGNAL TYPE. IT WAS FURTHER STATED THE FAILSAFES WERE NOT WORKING. THE MONITORS WERE RECEIVING POWER, BUT DID NOT DISPLAY ANY SIGNAL. WHEN BOTH MONITORS ARE UNABLE TO RECEIVE ANY BUT THE MONITORS ARE RECEIVING POWER THIS INDICATES THAT EITHER THE ROUTE WAS NOT SELECTED, THE SOURCE WAS NOT POWERED ON OR THE SETTING ON THE MONITOR IS INCORRECT. ALTHOUGH THE EXACT ROOT CAUSE IS UNKNOWN AND BASED ON THE REPORTED FAILURE MODE, IT IS LIKELY THAT THE SOURCE THEY ARE TRYING TO ROUTE IS NOT POWERED ON. THERE IS NO REPORT OF ADVERSE CONSEQUENCES OR PATIENT INVOLVEMENT IN THIS EVENT. THERE WERE NUMEROUS ATTEMPTS TO CONTACT THE FACILITY WITH REGARD TO THIS ISSUE HOWEVER, THERE WAS NO RESPONSE. THIS NOT A SINGLE USE DEVICE.

    Description of Event or Problem · 1

    (B)(4). (B)(6) CALLED IN OPERATING ROOM 5: BOTH MONITORS IN ROOM ARE UNABLE TO RECEIVE ANY SIGNAL TYPE. FAILSAFES ARE NOT WORKING. MONITORS ARE RECEIVING POWER, BUT DID NOT DISPLAY ANY SIGNAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFINITY HIGH RES GCJ STRYKER COMMUNICATIONS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA