BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIREMOBIL COMPACT L

    MDR report key: 8915631 · Received August 21, 2019

    Report

    Report Number
    3004977335-2019-92854
    Event Type
    Malfunction
    Date Received
    August 21, 2019
    Date of Event
    July 22, 2019
    Report Date
    August 6, 2019
    Manufacturer
    SIEMENS HEALTHCARE GMBH
    Product Code
    OXO
    PMA / PMN Number
    K963093
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS HAS COMPLETED AN INVESTIGATION OF THE REPORTED EVENT. THE ROOT CAUSE WAS DETERMINED TO BE A HARDWARE ISSUE. THE INVESTIGATION WAS PERFORMED CONSIDERING COMPLAINT DESCRIPTION, CS REPORTS, SYSTEM LOG FILES AND SYSTEM HISTORY. THE ISSUE WAS CAUSED BY A DEFECTIVE D3 BOARD. IT WAS MENTIONED IN THE COMPLAINT THAT ABOUT 600 CGY * CM² DOSE WAS DISPLAYED VIA DOSE AREA PRODUCT (DAP) FOR TWO PATIENTS. THE RELATED SKIN DOSE AFTER CALCULATION IS 0.0298GY. THEREFORE, THE DOSE IS WITHIN A SAFE LEVEL EVEN IF IT IS SLIGHTLY HIGHER THAN USUAL. THE D3 PRINTED WIRING BOARD HAS BEEN EXCHANGED BY THE LOCAL SERVICE ORGANIZATION AND THE ERROR MENTIONED DID NOT REOCCUR. THE OCCURRENCE RATE OF THE IDENTIFIED CAUSE HAS BEEN CHECKED AND NO ERROR ACCUMULATION HAS BEEN IDENTIFIED. THE MANUFACTURER IS NOT CONSIDERING FURTHER ACTIONS RESULTING FROM THIS EVENT AS NO SYSTEMATIC ERROR HAS BEEN RECOGNIZED.

    Additional Manufacturer Narrative · 1

    SIEMENS IS CONDUCTING A THOROUGH INVESTIGATION OF THE REPORTED EVENTS. AS THIS EVENT IS UNDER INVESTIGATION, A ROOT CAUSE HAS NOT YET BEEN DETERMINED. A SUPPLEMENT REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE SIREMOBIL COMPACT L SYSTEM. THE CUSTOMER HAS REPORTED DOSE REGULATION ISSUES DURING EXAMS. THERE IS NO REPORT OF IMPACT TO THE STATE OF HEALTH OF ANY PATIENT OR USER INVOLVED. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709844 SIREMOBIL COMPACT L IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE OXO SIEMENS HEALTHCARE GMBH 3780629

    Patients

    Seq Age Sex Outcome Treatment
    1