BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLAT PANEL SPRING ARM, EDS SUSPENSION 15-21KG

    MDR report key: 1944691 · Received December 7, 2010

    Report

    Report Number
    2031963-2010-00134
    Event Type
    Malfunction
    Date Received
    December 7, 2010
    Date of Event
    November 11, 2010
    Report Date
    November 11, 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
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PT INVOLVEMENT, THUS NO PT DATA EXISTS. THERE IS NO EXPIRATION DATE FOR THIS PRODUCT. ACTUAL DEVICE WAS EVALUATED IN THE FIELD ON (B)(6) 2010. EVALUATION SUMMARY: AFTER EVALUATION BY THE FIELD SERVICE TECH AND THE INVESTIGATOR, IT WAS FOUND THAT THE MONITOR WAS HANGING BY THE CABLES AND THAT SEVERAL COMPONENTS WERE NOT IN PLACE INCLUDING THE KEEPER CLIP, M3 SCREW, AND SAFETY SEGMENT COLLAR. IT WAS ALSO DISCOVERED THAT THE ROOM WAS RECENTLY INSTALLED BY A COMPETITOR, OLYMPUS, AND WAS BEING USED FOR THE INTEGRATION (AUDIO/VIDEO) WITH THEIR DEVICES. BASED ON THE EVIDENCE ON THE COVERS OF THE SPRING ARM NOT BEING ATTACHED CORRECTLY AND THE MISSING COMPONENTS, THE NON-CONFORMANCE IS LIKELY DUE TO RE-ASSEMBLY ERROR BY THE COMPETITOR COMPANY WHEN ROUTING CABLES THROUGH THE STRYKER SPRING ARMS. UPON ARRIVAL AND EVALUATION, THE FIELD SERVICE TECH REPLACED THE SPRING ARM COVERS, M3 SCREW, KEEPER CLIP, AND SAFETY SEGMENT. WITH THIS MALFUNCTION, THE FLAT PANEL YOKE CAN 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 PTS WERE INVOLVED AND NO ADVERSE EVENTS WERE REPORTED. THIS TYPE OF NON-CONFORMANCE WILL BE MONITORED FOR ADVERSE TRENDS. THIS IS NOT A SINGLE USE DEVICE.

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT ONE OF THE VISION ELECT (B)(4) MONITORS IN (B)(6) IS HANGING FROM THE FLAT PANEL CABLE KIT AND THE SAFETY SEGMENT WAS NOT IN PLACE. UPON FURTHER EVALUATION, IT WAS FOUND THAT THE KEEPER CLIP AND M3 SCREW WERE MISSING. THERE WAS NO REPORTED PT INVOLVEMENT, AND NO REPORTED ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLAT PANEL SPRING ARM, EDS SUSPENSION 15-21KG BRY STRYKER COMMUNICATIONS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA