BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIGID ARM SUPPORT, STANDARD AND LARGE

    MDR report key: 6752113 · Received July 28, 2017

    Report

    Report Number
    1932738-2017-00001
    Event Type
    Malfunction
    Date Received
    July 28, 2017
    Date of Event
    March 15, 2017
    Report Date
    July 28, 2017
    Manufacturer
    MEDTEC, INC. D/B/A CIVCO MEDICAL SOLUTIONS
    Product Code
    IYE
    PMA / PMN Number
    K060737
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RISK: DUE TO THE POTENTIAL HEIGHT VARIATION IN THE RIGID ARM SUPPORTS THERE IS POTENTIAL FOR MISTREATMENT IF THERE ARE MULTIPLE DEVICES IN THE FACILITY THAT HAVE VARYING HEIGHTS BETWEEN SIMULATION AND TREATMENT. IF THE PATIENT WAS SIMULATED AND TREATED ON EQUIVALENT SYSTEMS BUT DURING TREATMENT ANOTHER SYSTEM WAS INTRODUCED WITH ARM SUPPORT HEIGHT VARIATION AND WAS NOT VERIFIED TO BE EQUIVALENTLY SETUP THROUGH IMAGING THERE IS RISK FOR MISTREATMENT. THE RIGID ARM SUPPORTS DO NOT HAVE ANY SPECIFIC CLAIMS MADE FOR ACCURACY OR REPEATABILITY OF THE SYSTEM AND THE RIGID ARM SUPPORTS ARE INTENDED FOR PATIENT COMFORT, GENERAL POSITIONING, AND TO KEEP THE ARMS OUT OF THE TREATMENT AREA ONLY. DUE TO THE NATURE OF BREAST TREATMENT THE BREASTS MOVE AS THE PATIENT BREATHES AND THEREFORE TREATMENT MARGINS ARE HIGH. BREAST SET-UP REPRODUCIBILITY AND THE PATIENT CHEST WALL MOTION DUE TO BREATHING, RESULTS IN BREAST TREATMENT MARGINS LIKELY IN THE 5-10 MM RANGE. CHANGES IN ARM POSITION DUE TO VARYING ARM SUPPORTS WILL IMPACT THE POSITION OF THE CHEST WALL AND BREAST POSITION. A 16.8 MM VARIATION IN ARM POSITIONER COULD RESULT IN CHEST/BREAST/HEART POSITION CHANGES WHICH EXCEED EXPECTED TREATMENT PLANNING MARGINS. MITIGATIONS: WHEN TRANSFERRING FROM SIMULATION TO TREATMENT AND PRIOR TO EACH TREATMENT THERE WILL ALWAYS BE SOME TYPE OF ALIGNMENT, EITHER THROUGH A PRE-TREATMENT IMAGE WHICH WOULD BE CONDUCTED APPROXIMATELY TWICE PER WEEK OR ALIGNING OF THE SKIN MARKS. ADDITIONALLY, PRIOR TO EACH TREATMENT THE SOURCE TO SKIN DISTANCE (SSD) IS MEASURED AND IF THERE WAS MISALIGNMENT DUE TO ARM SUPPORT HEIGHT VARIATION THE SSD WOULD HAVE VARIED. VARIATION NOTED IN THE PRE-TREATMENT IMAGE, ALIGNMENT TO SKIN MARKERS, OR SSD WOULD REQUIRE INVESTIGATION BY THE THERAPIST OR PHYSICIST AND THEREFORE SETUP VARIATION WOULD BE DETECTED. THE VERIFICATION OF ALIGNMENT IS COMMUNICATED PER IFU 143-104 REV. D (POSIREST) AND 143-150 REV. D (POSIBOARD) THROUGH THE WARNING "VERIFY ALL ANGLES OF TREATMENT AND ATTENUATION CHARACTERISTICS PRIOR TO TREATING PATIENTS."

    Description of Event or Problem · 1

    END USER RECEIVED A RIGID ARM SUPPORT SET (PN: 106015), AS PART OF THEIR POSIREST-2 SYSTEM (PN: 106521). WHEN THE NEW POSIREST-2 SYSTEM WAS VISUALLY COMPARED TO THEIR UNIT SHIPPED IN 2010, THE HEIGHT OF THE NEW UNIT WAS SIGNIFICANTLY DIFFERENT THAN THEIR OLD UNIT. THE END USER FAILED THEIR INCOMING INSPECTION AND DID NOT PUT THEIR UNIT INTO SERVICE. CIVCO ISSUED (B)(4) FOR THIS COMPLAINT (B)(6) 2017. SINCE INITIATION OF THE COMPLAINT INVESTIGATION AND SOURCING OF EQUIVALENT PRODUCT WAS NECESSARY TO PERFORM INSPECTIONS TO DETERMINE THE TRUE VARIATION FROM PART TO PART. ON JUNE 23RD HEALTH HAZARD ANALYSIS # 58 WAS APPROVED AND PRESENTED TO MANAGEMENT FOR CONFIRMATION OF THE FIELD ACTION WHICH WAS CONFIRMED ON JULY 10TH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532681 RIGID ARM SUPPORT, STANDARD AND LARGE RIGID ARM SUPPORT, STANDARD AND LARGE IYE MEDTEC, INC. D/B/A CIVCO MEDICAL SOLUTIONS 106015, 106047, 106020, 106521, 109303, 109040, 106048, 106522

    Patients

    Seq Age Sex Outcome Treatment
    1