BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYMOBIL PLUS

    MDR report key: 17404579 · Received July 27, 2023

    Report

    Report Number
    3004977335-2023-00067
    Event Type
    Malfunction
    Date Received
    July 27, 2023
    Date of Event
    December 1, 2022
    Report Date
    July 27, 2023
    Manufacturer
    SIEMENS HEALTHCARE GMBH
    Product Code
    IZL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS DEVICE IS NOT AN FDA 510(K) CLEARED MEDICAL DEVICE BUT IS SIMILAR TO THE MOBILETT XP WHOSE 510(K) NUMBER IS K033238. THE MANUFACTURER HAS RECEIVED CLARIFICATION ON 2023-07-24 THAT MDRS ARE REQUIRED FOR SIMILAR DEVICES MARKETED BY THE MANUFACTURER, EVEN IF IT IS NOT 510(K) CLEARED OR IMPORTED TO THE UNITED STATES. THEREFORE, A RETROSPECTIVE REVIEW WAS CONDUCTED BACK TO JANUARY 1, 2022, AND THIS COMPLAINT WAS REEVALUATED. SINCE THIS DEVICE IS SIMILAR TO THE MOBILETT XP, WHICH IS MARKETED IN THE UNITED STATES, IT IS NOW DEEMED THAT THIS COMPLAINT MEETS THE REQUIREMENTS FOR REPORTING UNDER 21 CFR 803. E1: THE CUSTOMER FACILITY CONTACT PHONE NUMBER IS (B)(6). H3, H6: SIEMENS COMPLETED THE INVESTIGATION OF THE COMPLAINT ISSUE. IT WAS STATED THAT THE COLLIMATOR CAME LOOSE FROM THE TUBE DURING AN EXAMINATION AS THE PINS SECURING THE COLLIMATOR WERE NOT TIGHTENED ENOUGH. THE COLLIMATOR DID NOT FALL OFF COMPLETELY FROM THE SINGLE TANK FLANGE. NO PATIENT OR OTHER PERSONS WERE INJURED. ACCORDING TO THE RECEIVED INFORMATION, THE SERVICE ENGINEER DID NOT DETECT ANY DAMAGE ON THE COLLIMATOR AND THE TUBE. ALL MECHANICAL PARTS WERE FINE. NO GENERAL HARDWARE PROBLEM WAS IDENTIFIED. THE PROVIDED IMAGES ALSO DO NOT SHOW ANY MECHANICAL PROBLEM OF THE SINGLE TANK FLANGE AND THE FOUR FIXATION CLAMPS ON THE COLLIMATOR. ONLY SCRATCHES DUE TO NORMAL WEAR ARE VISIBLE. THE LAST MAINTENANCE ON THE AFFECTED SYSTEM WAS PERFORMED ON 18.08.2022. BASED ON THE PROVIDED MAINTENANCE PROTOCOL, NO DEFICIENCIES REGARDING THE COLLIMATOR TESTS WERE FOUND. SINCE THE COLLIMATOR IS TURNED DURING THIS MAINTENANCE, A LOOSE FIXATION COULD HAVE BEEN DETECTED. ON THE AFFECTED SYSTEM, SERVICE INTERVENTIONS HAD BEEN PERFORMED IN SEPTEMBER AND NOVEMBER 2022 BEFORE THE LOOSE COLLIMATOR WAS DETECTED. DURING THESE, A COLLIMATOR, AND LATER A CABLE TO THE SINGLE TANK AND THE COLLIMATOR WERE REPLACED. WHEN REPLACING THESE PARTS, THE COLLIMATOR HAD TO BE DISMOUNTED FROM THE SINGLE TANK. IT IS ASSUMED THAT THE COLLIMATOR WAS NOT MOUNTED CORRECTLY DURING THIS WORK. IF THE FOUR (4) PINS SECURING THE COLLIMATOR TO THE FLANGE OF THE SINGLE TANK WERE NOT MOVED OUT COMPLETELY THIS MAY HAVE LED TO THE LOOSE COLLIMATOR. IT IS DESCRIBED IN THE REPLACEMENT OF SYSTEM PARTS DOCUMENT HOW TO REMOUNT THE COLLIMATOR ON THE FLANGE OF THE SINGLE TANK. THE FOUR (4) PINS NEED TO BE TIGHTENED WITH A FORCE OF 0.75 NM TO ENSURE THAT THE COLLIMATOR IS CORRECTLY MOUNTED ON THE SINGLE TANK FLANGE. ACCORDING TO THE SERVICE ORGANIZATION THE COLLIMATOR WAS REMOUNTED ON THE SINGLE TANK FLANGE ON SITE WITH FOUR (4) CLAMPS (PINS) AFTER THE INCIDENT. IN GENERAL, A LOOSE COLLIMATOR COULD ALSO BE DETECTED BY THE CUSTOMER DURING THE REQUIRED DAILY CHECKS AS DESCRIBED IN THE SYSTEM USER MANUAL. IT COULD NOT BE CONFIRMED BY THE SERVICE ENGINEER THAT THE CUSTOMER ALWAYS PERFORMS THESE CHECKS. THE COMPLAINT IS CLOSED WITH THIS STATEMENT AND WITHOUT FURTHER MEASURES.

    Description of Event or Problem · 0

    DURING A PATIENT EXAMINATION THE USING THE POLYMOBIL PLUS, THE COLLIMATOR BECAME LOOSE BUT DID NOT FALL OFF COMPLETELY. NO INJURY OCCURRED IN THIS CASE. IF THE COLLIMATOR WOULD BECOME COMPLETELY LOOSE, THERE IS A HIGH CHANCE THAT IT WOULD BE HELD BY THE CABLES. NEVERTHELESS, IT IS ASSUMED THAT IN WORST-CASE SCENARIO A FALLING COLLIMATOR COULD HIT A PATIENT OR OTHER PERSON AND CAUSE A MINOR TO SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672483 POLYMOBIL PLUS SYSTEM, X-RAY, MOBILE IZL SIEMENS HEALTHCARE GMBH 10187800

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown