BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOBILETT ELARA MAX

    MDR report key: 11037780 · Received December 18, 2020

    Report

    Report Number
    3002808157-2020-58483
    Event Type
    Malfunction
    Date Received
    December 18, 2020
    Date of Event
    December 3, 2020
    Report Date
    December 18, 2020
    Manufacturer
    SIEMENS HEALTHCARE GMBH
    Product Code
    IZL
    UDI-DI
    04056869154992
    PMA / PMN Number
    K182639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE ISSUE WAS INVESTIGATED IN DETAIL AND BASED ON INFORMATION FROM SIMILAR CASES. THE COLLIMATOR COVER IS FIXATED BY FOUR SCREWS ON TWO HOLDERS, WHICH ARE PART OF THE COLLIMATOR. THE MOUNTING BRACKETS ARE PRODUCED WITH STEEL SHEET METAL BENT TO 90° WITH THE ADDITION OF FOUR THREADED INSERTS. THE HOUSING IS MOUNTED TO THESE FOUR THREADED INSERTS. UPON INVESTIGATION, IT WAS DISCOVERED THAT THE SHEET METAL HAD BEEN BENT TWO TIMES IN OPPOSITE DIRECTIONS, THUS WEAKENING THE PIECE. AS A RESULT, THE SUB SUPPLIER WAS CHANGED. FURTHERMORE, THE DESIGN WAS MODIFIED TO ENSURE ADDITIONAL STRENGTH OF THE PIECE; VISUAL CHECKS WERE IMPLEMENTED TO ENSURE THE PIECE WAS NEITHER BROKEN NOR BENT TWO TIMES. THESE MENTIONED IMPROVEMENTS ON THE BRACKETS HAVE BEEN ALREADY INTRODUCED BY THE SUPPLIER FOR COLLIMATORS USED FOR MOBILETT ELARA UNITS, STARTING WITH SERIAL NUMBER (B)(6) (IN COMBINATION WITH COLLIMATOR SERIAL NUMBER (B)(6)). THIS COLLIMATOR IS USED ON TWO SYSTEM TYPES WITH DIFFERENT PART NUMBERS. MOBILETT MIRA MAX (10519819), MOBILETT ELARA MAX (11364066). ACCORDING TO THE USER MANUAL (XPR8-270G.620.03.01.02, PAGE 123), THE USER MUST PERFORM A DAILY CHECK OF FUNCTION AND SECURITY. IF DAMAGED OR LOOSE PARTS ARE FOUND, THE SYSTEM MAY NOT BE USED UNTIL REPAIR WAS PERFORMED. THE DESCRIBED ISSUE WAS RESOLVED AT THE CONCERNED CUSTOMER SITE BY SIEMENS LOCAL SERVICE TECHNICIAN REPLACING THE AFFECTED PART.

    Additional Manufacturer Narrative · 0

    SIEMENS IS SUBMITTING THIS CORRECTION TO THE INITIAL ADVERSE EVENT REPORT. AN ERROR WAS MADE IN THE NAME OF THE SUSPECT MEDICAL DEVICE. THE INITIALLY REPORTED DEVICE WAS MOBILETT MIRA MAX, HOWEVER, THE CORRECT DEVICE IS MOBILETT ELARA MAX. THE 510K # WAS CORRECTED TO K182639 AS WELL.

    Additional Manufacturer Narrative · 1

    THE COLLIMATOR IS FIXED WITH TWO SCREWS ON EACH BRACKET. THEREFORE, THE BREAKING OF ONE BRACKET WILL ONLY RESULT IN THE COLLIMATOR BEING DISLOCATED AT ONE SIDE. IT WILL NOT FALL OFF COMPLETELY AND THERE IS NO RISK THAT A PERSON IS INJURED BY A FALLING COLLIMATOR. IT IS DESCRIBED IN THE OPERATOR MANUAL TO PERFORM A DAILY CHECK FOR DAMAGED OR LOOSE PARTS AND HAVE THE SYSTEM REPAIRED IF PROBLEMS ARE FOUND. ONLY IN THE UNLIKELY EVENT THAT BOTH BRACKETS BREAK, THE COLLIMATOR COULD FALL DOWN. HOWEVER, IT WOULD MOST LIKELY BE HELD BY THE CABLES. SIEMENS IS CONDUCTING A THOROUGH INVESTIGATION OF THE EVENT. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. INTERNAL ID # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO SIEMENS THAT DURING SERVICE ACTIVITIES ON THE MOBILETT MIRA MAX SYSTEM, SIEMENS ENGINEER DISCOVERED THAT THE ONE SIDE OF THE COLLIMATOR COVER SAGGED DOWN EVEN THOUGH THE BOLTS WERE TIGHTLY SCREWED. IT WAS DETERMINED THAT ONE OF THE METAL MOUNTING BRACKETS WAS BROKEN DURING THE MANUFACTURING AT THE SPOT WHERE THE BRACKET BENTS. THE ISSUE HAD NOT BEEN NOTICED BY THE USER DUE TO THE COLLIMATOR COVER SITTING TIGHT ON THE FRAME. THERE ARE NO INJURIES ATTRIBUTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1498995 MOBILETT ELARA MAX MOBILE X-RAY SYSTEM. IZL SIEMENS HEALTHCARE GMBH 11107444 04056869154992

    Patients

    Seq Age Sex Outcome Treatment
    1 Other