BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONCOR IMPRESSION PLUS

    MDR report key: 8217930 · Received January 4, 2019

    Report

    Report Number
    3002466018-2018-61191
    Event Type
    Malfunction
    Date Received
    January 4, 2019
    Date of Event
    December 13, 2018
    Report Date
    December 13, 2018
    Manufacturer
    SIEMENS HEALTHCARE GMBH
    Product Code
    IYE
    PMA / PMN Number
    K060226
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS COMPLETED AN INVESTIGATION OF THE REPORTED EVENT. THE FUNCTIONALITY OF THE COLLISION PROTECTION SYSTEM AT THE CUSTOMER FACILITY HAS BEEN CHECKED. NO MALFUNCTION COULD BE IDENTIFIED. THE FORCE APPLIED FROM ANY DIRECTION IS BELOW THE VALUE SPECIFIED BY THE RISK ASSESSMENT "EVALUATION OF THE PATIENT HAZARD DUE TO COLLISION WITH FPP". THE MOTION STOP WAS NOT SET BECAUSE THE APPLIED FORCE AT THE COLLISION WAS MOST PROBABLY UNDER THE THRESHOLD. THERE WAS AN UNFORTUNATE CORRELATION BETWEEN THE WEAK COLUMN BRAKES WHICH ALLOWED THE ECCENTRIC TABLE MOVEMENT WITHOUT CAUSING THE MOTION STOP INTERLOCK TO DROP. FURTHER ACTION IS NOT WARRANTED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2017019. (B)(4). SIEMENS HAS INITIATED A TECHNICAL INVESTIGATION OF THE REPORTED EVENT. A ROOT CAUSE HAS NOT YET BEEN IDENTIFIED. A SUPPLEMENTAL REPORT WILL BE FILED UPON THE COMPLETION OF THE INVESTIGATION. (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED TO SIEMENS THAT DURING TREATMENT OF A PATIENT WITH THE ONCOR IMPRESSION PLUS SYSTEM, THE FLAT PANEL POSITIONER (FPP) TOUCHED THE PATIENT TREATMENT TABLE WHILE THE GANTRY WAS ROTATING. THE USER FURTHER REPORTED THAT THE TOUCH-GUARD OF THE FPP IS NOT SENSITIVE ENOUGH AND THE SETTING SENSITIVITY OF THE FPP COLLISION INTERLOCK (IL) IS NOT SUFFICIENT. THE TREATMENT WAS COMPLETED. THIS EVENT DID NOT RESULT IN PATIENT INJURY, HOWEVER, IF THE USER IS NOT AWARE OF THE REPORTED SYSTEM BEHAVIOR AS DESCRIBED IN THE USER MANUAL AND DOES NOT PERFORM A "DRY RUN" PRIOR TO THE TREATMENT OF A PATIENT, COLLISION OF THE SYSTEM WITH THE PATIENT COULD OCCUR AND RESULT IN SEVERE BODILY INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11142 ONCOR IMPRESSION PLUS ACCELERATOR, LINEAR, MEDICAL IYE SIEMENS HEALTHCARE GMBH 5857912

    Patients

    Seq Age Sex Outcome Treatment
    1