BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIDMARK/PROGENY

    MDR report key: 4202964 · Received September 17, 2014

    Report

    Report Number
    2438474-2014-00002
    Event Type
    Malfunction
    Date Received
    September 17, 2014
    Date of Event
    September 6, 2014
    Report Date
    September 11, 2014
    Manufacturer
    QUANTUM MEDICAL IMAGING, LLC.
    Product Code
    IZW
    PMA / PMN Number
    K810598
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER DISCUSSION WITH FIRM CONTRACTED WITH SYSTEM INSTALLATION, IT WAS CONCLUDED THAT THE REPORTED INCIDENT WAS A RESULT OF OVERSIGHT BY THE SYSTEM INSTALLATION STAFF INT HE PROPER SELECTION AND USE OF COLLIMATOR MOUNTING HARDWARE DURING SYSTEM SET-UP. REFER TO ATTACHED INVESTIGATION REPORT DATED (B)(4) 2014.

    Description of Event or Problem · 1

    ON SATURDAY (B)(6) AT APPROXIMATELY 3:00 PM CST WE HAD A SITUATION WITH TH EX-RAY ROOM WE HAD PURCHASED FORM QUANTUM I HAVE ATTACHED PICTURES FOR YOUR REVIEW. IT APPEARS THAT WHEN USING THE BOLTS SUPPLIED WITH THE COLLIMATOR THERE IS NOT ENOUGH TREADS IN THE TUBE PORT MOUNTING PLATE TO HOLD THE COLLIMATOR IN PLACE. IN THIS CASE THE BOLTS LET GO AND THE COLLIMATOR IN PLACE IN THIS CASE THE BOLTS LET GO AND THE COLLIMATOR FELL OFF. FORTUNATELY THERE WAS NOT A PATIENT UNDER THE COLLIMATOR SO NO ONE WAS HUT. THE SAME FIELD ENGINEERS INSTALLED THIS ROOM THAT HAVE DONE OVER 40 ROOMS IN THE LAST 4 TO 5 YEARS AND WE HAVE NEVER EXPERIENCED THIS BEFORE. I HAVE MANY MORE PICTURES AS WELL AS THE SERIAL NUMBERS OF THE TUBE AND COLLIMATOR. THE ISSUE IS THAT THE BOLTS ARE 1/4 TO 1/2 INCH SHORT IN LENGTH. SINCE THE OPERATOR HAD NOT CONTROL FOR THE TUBESTAND IS ALSO MOUNTED WITH THESE BOLTS THERE IS A CONSTANT PRESSURE APPLIED TO THESE BOLTS EVERY TIME THE TUBESTAND IS MOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575391 MIDMARK/PROGENY DIAGNOSTIC X-RAY BEAM-LIMITING DEVICE IZW QUANTUM MEDICAL IMAGING, LLC. MC-150

    Patients

    Seq Age Sex Outcome Treatment
    1