BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGHT HEAD, CAMERA RDY, VISUM

    MDR report key: 1949044 · Received December 28, 2010

    Report

    Report Number
    2031963-2010-00138
    Event Type
    Malfunction
    Date Received
    December 28, 2010
    Date of Event
    November 30, 2010
    Report Date
    November 30, 2010
    Manufacturer
    STRYKER COMMUNICATIONS
    Product Code
    FSY
    PMA / PMN Number
    K031068
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THERE WAS NO PT INVOLVEMENT, THUS NO PT DATA EXISTS. THE SERIAL NUMBER WAS UNK AT THE TIME OF THIS REPORT. FURTHER ATTEMPTS WILL BE MADE FOR THIS INFO. THERE IS NO EXPIRATION DATE FOR THIS PRODUCT. ACTUAL DEVICE WAS EVALUATED BY THE SITE BIO-MED VIA TELECONFERENCE. DEVICE IS NOT AVAILABLE FOR EVALUATION AT THE TIME OF THIS REPORT. THE CRACKED COVERS WERE REQUESTED TO BE RETURNED FOR EVALUATION, BUT THEY HAVE NOT BEEN RECEIVED YET. DEVICE PROBLEM HAS BEEN EVALUATED WITH SIMILAR DEVICES AND VIA THE SERVICE HISTORY OF THE ACCOUNT, AND ROOT CAUSE IS LIKELY KNOWN. EVALUATION SUMMARY: AFTER AN INITIAL INVESTIGATION VIA TELECONFERENCE BETWEEN THE INVESTIGATOR AND THE ONSITE BIO-MED, THE BIO-MED ADDED THAT ONE OF THE COVERS IN OPERATING ROOM 9 HAD FALLEN OFF A LIGHT FLAT PANEL SUSPENSION WHILE PREPARING FOR A CASE. THE TEA CUP COVER FELL BECAUSE THERE WAS A CRACK ON IT WHERE THE SCREWS ARE ATTACHED AND DAMAGED TO THE POINT OF FALLING OFF. THREE ADDITIONAL COVERS WERE REFERENCED IN THE ORIGINAL COMPLAINT. IT IS UNK WHETHER THE ADDITIONAL CRACKED COVERS WERE DAMAGED TO THE POINT OF HAVING THE POTENTIAL TO FALL. MORE INFO WILL BE PROVIDED IN A SUPPLEMENTAL IF OBTAINED. IN THIS CASE, REPLACEMENT COVERS WERE SENT TO THE ACCOUNT, AND THE SITE BIO-MED REPLACED THE CRACKED COVERS. IT WAS REQUESTED TO RETURN THE CRACKED COVERS TO THE MANUFACTURE FOR FURTHER EVALUATION, BUT THE COVERED HAVE NOT BEEN RECEIVED YET. THE LIKELY ROOT CAUSE IS FROM USER MISUSE COLLIDING EQUIPMENT AGAINST THE COVERS CAUSING DAMAGE. THE OPERATIONS AND MAINTENANCE MANUAL INSTRUCTS THE USER TO PERFORM AN ANNUAL PREVENTIVE MAINTENANCE FOR DAMAGES TO PLASTIC COMPONENTS. A SERVICE REQUEST WAS MADE FOR THE SAME ACCOUNT IN (B)(6) 2009 FOR THE SAME ISSUE IN OPERATING ROOMS (B)(6). IN ADDITION TO THIS SERVICE REQUEST, THERE ARE OTHER SERVICE REQUESTS FROM THE SAME ACCOUNT THAT INDICATES ABUSE OF THE EQUIPMENT. SEVERAL DAMAGED/BROKEN COMPONENTS OF THE EQUIPMENT HAVE BEEN REPORTED WHICH IS AN INDICATION OF ABUSE TO THE EQUIPMENT. EXAMPLES OF THIS ARE DAMAGED MECHANICAL STOPS AND OTHER PLASTIC COMPONENTS BEING DAMAGED. THIS TYPE OF MALFUNCTION POSES A MODERATE RISK TO A PT IF THE TEA CUP COVER FALLS INTO THE STERILE FIELD OF THE PT. THIS SPECIFIC MALFUNCTION WAS IDENTIFIED PRIOR USE AND NO PATIENTS 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 OPERATING ROOMS (B)(6) VISUM 600 ARE MISSING THE TEA CUP COVERS FOR THE LIGHT FLAT PANEL SUSPENSIONS. AFTER FURTHER EVALUATION, IT WAS REPORTED THAT ON THE COVERS IN OPERATING ROOM (B)(6) HAD FALLEN OFF A LIGHT FLAT PANEL SUSPENSION WHILE PREPARING FOR A CASE. THERE WAS NO REPORTED PT INVOLVEMENT, AND NO REPORTED ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGHT HEAD, CAMERA RDY, VISUM FSY STRYKER COMMUNICATIONS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA