BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVICE HEAD, 750MM

    MDR report key: 1651861 · Received April 1, 2010

    Report

    Report Number
    2031963-2010-00058
    Event Type
    Malfunction
    Date Received
    April 1, 2010
    Date of Event
    March 11, 2010
    Report Date
    March 30, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT DOES NOT HAVE AN EXPIRATION DATE DEVICE MANUFACTURING DATE IS UNKNOWN AT THIS TIME. EVALUATION SUMMARY: UPON THE EVALUATION OF THE PRODUCT, IT WAS FOUND THAT THE BOLTS THAT HOLD THE SHAPE ARM TO THE BOOM WERE WORN AND STRIPPED OUT. THE SHAPE ARM HAS BEEN INSTALLED SINCE 2005 AND HAS BEEN USED FREQUENTLY WITHIN THE OPERATING ROOM. THIS CONSTANT MOVEMENT CAUSED THE BOLTS WHICH HOLD THE SHAPE ARM TO THE BOOM TO BORE OUT OVER TIME. THIS CAUSED THE SHAPE ARM TO BECOME LOOSE AND EVENTUALLY FALL. THIS TYPE OF ATTACHMENT IS NO LONGER USED BY STRYKER COMMUNICATIONS. NEW SHAPE ARM HAS BEEN INSTALLED. THIS NOT A SINGLE USE DEVICE. OTHER: AT THIS POINT IN TIME IT IS UNKNOWN HOW THE PTZ CAMERA WAS MOUNTED TO THE MONITOR.

    Description of Event or Problem · 1

    DURING THE PREPARATION FOR THE CAUSE THE HOSPITAL STAFF MOVED THE MONITOR ON THE BAM SHAPE ARM WHICH IS ATTACHED TO THE EQUIPMENT BOOM. SUBSEQUENTLY THE MONITOR AND ARM LOOSENED FROM THE BOOM AND WERE HANGING BY THE CABLES AND THE PTZ CAMERA THAT WAS ATTACHED TO THE MONITOR FELL ON THE NURSE. THE NURSE CONFIRMED THAT THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THE CAMERA FALLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERVICE HEAD, 750MM BRY STRYKER COMMUNICATIONS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA