BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL FLAT PANEL YOKE, LANDSCAPE

    MDR report key: 1964114 · Received December 21, 2010

    Report

    Report Number
    2031963-2010-00136
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    November 23, 2010
    Report Date
    November 23, 2010
    Manufacturer
    STRYKER COMMUNICATIONS
    Product Code
    BRY
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT INVOLVEMENT, THUS NO PATIENT DATA EXISTS. THERE IS NO EXPIRATION DATE FOR THIS PRODUCT. ACTUAL DEVICE WAS EVALUATED IN THE FIELD ON (B)(6) 2010. THE MANUFACTURE DATE OF THE DEVICE IS UNKNOWN AT THE TIME OF THIS REPORT. ATTEMPTS WILL BE MADE TO OBTAIN THIS INFORMATION. EVALUATION SUMMARY: AFTER EVALUATION BY THE FIELD SERVICE TECHNICIAN, IT WAS FOUND THAT THE M3 SCREW WAS MISSING. THE ROOT CAUSE OF THE MISSING M3 SCREW IS UNKNOWN AT THE TIME OF THIS REPORT. FURTHER INVESTIGATION WILL BE MADE TO DETERMINE ROOT CAUSE. UPON ARRIVAL AND EVALUATION, THE FIELD SERVICE TECHNICIAN REINSTALLED THE M3 SCREW, AND VERIFIED SCREW WAS SECURE. THE M3 SCREW IS A CRITICAL COMPONENT OF THE YOKE ASSEMBLY. THE M3 SCREW HOLDS THE SAFETY SEGMENT IN PLACE. IF THE SCREW IS MISSING THE SAFETY SEGMENT CAN MOVE OUT OF POSITION WITH NORMAL MOVEMENT OF THE MONITOR. IF THE SAFETY SEGMENT IS OUT OF PLACE, THE KEEPER CLIP HAS THE POTENTIAL OF COMING OUT OF PLACE WITH NORMAL MOVEMENT OF THE MONITOR. WITH THIS MALFUNCTION, THE KEEPER CLIP CAN COME OUT OF PLACE WHICH WILL CAUSE THE FLAT PANEL YOKE TO BECOME DETACHED FROM THE SPRING ARM. IF IT DOES, THE YOKE WILL ONLY DROP A COUPLE OF INCHES AS THE CABLE KIT WILL HOLD THE YOKE. THIS TYPE OF MALFUNCTION POSES A MODERATE RISK IF THE MONITOR ASSEMBLY WERE TO DROP ON A USER STANDING UNDERNEATH THE MONITOR AT THE TIME OF FAILURE. HOWEVER, THIS SPECIFIC MALFUNCTION WAS IDENTIFIED PRIOR TO USE IN A CASE, AND NO PATIENTS WERE INVOLVED AND NO ADVERSE EVENTS WERE REPORTED. THIS TYPE OF NON-CONFORMANCE WILL BE MONITORED FOR ADVERSE TRENDS.

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT THE M3 SCREW WAS FAULTY FOR MONITOR 1 IN OPERATING ROOM (B)(6). THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS MALFUNCTION, BUT THERE IS A POTENTIAL FOR EQUIPMENT TO FALL WHEN THE M3 SCREW IS NOT IN PLACE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIVERSAL FLAT PANEL YOKE, LANDSCAPE BRY STRYKER COMMUNICATIONS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA