BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUAL AXIS LIGHT/FP

    MDR report key: 2120404 · Received May 27, 2011

    Report

    Report Number
    2031963-2011-00030
    Event Type
    Malfunction
    Date Received
    May 27, 2011
    Date of Event
    April 13, 2011
    Report Date
    April 13, 2011
    Manufacturer
    STRYKER COMMUNICATIONS
    Product Code
    BRY
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT INVOLVEMENT, THUS NO PATIENT DATA EXISTS. THERE IS NO EXPIRATION DATE FOR THIS PRODUCT. REPLACEMENT PART WAS GIVEN TO THE ACCOUNT ON (B)(6) 2011 FOR REPAIR. THE MANUFACTURE DATE OF THE DEVICE WAS UNKNOWN AT THE TIME OF THIS REPORT. EVALUATION SUMMARY: DURING A VISUAL EXAMINATION AT THE ACCOUNT IT WAS NOTED THAT THE CENTRAL AXIS COVER ON THE LIGHT SUSPENSION UNIT IS CRACKED ON THE BACK SIDE AND BOTH SIDES OF THE FASTENER SCREW. THIS IS A POTENTIAL HEALTH RISK DUE TO THE NATURE OF THE CRACK. IF THE PIECES OF THE CAP FELL INTO THE STERILE FIELD, THEY COULD COMPROMISE THE STERILE FIELD. THE COVER WILL BE REPLACED AS SOON AS POSSIBLE.

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT THERE WAS A BROKEN CENTRAL AXIS COVER ON THE LIGHT/FLAT PANEL MONITOR SUSPENSION IN THE OPERATING ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUAL AXIS LIGHT/FP BRY STRYKER COMMUNICATIONS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA