BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOMATOM EMOTION 16 (2007)

    MDR report key: 17263301 · Received July 5, 2023

    Report

    Report Number
    3003202425-2023-00003
    Event Type
    Injury
    Date Received
    July 5, 2023
    Date of Event
    May 18, 2023
    Report Date
    July 5, 2023
    Manufacturer
    SIEMENS SHANGHAI, MEDICAL EQUIPMENT LTD.
    Product Code
    JAK
    PMA / PMN Number
    K050297
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1: A FACILITY CONTACT NAME WAS NOT PROVIDED. THE REPORTING FACILITY TELEPHONE NUMBER IS (B)(4). H3, H6: THE SYSTEM INSTRUCTIONS FOR USE CLEARLY INDICATE THE FOLLOWING INFORMATION AND INSTRUCTION ALONG WITH ADDITIONAL CAUTIONS HIGHLIGHTED IN THE MANUAL: IF NECESSARY, IMMOBILIZE THE PATIENT WITH ONE OR MORE RESTRAINT STRAPS, SUCH THAT THE PATIENT IS CENTERED ON THE TABLE WITH THE EXTREMITIES SECURED. TAKE SPECIAL CARE WITH THOSE PATIENTS. ALWAYS FIX AND OBSERVE THE PATIENT DURING MEASUREMENT. ALWAYS OBSERVE THE PATIENT DURING SYSTEM MOVEMENTS. BASED ON THE INFORMATION ABOVE, THIS ISSUE WAS DUE TO THE PATIENT (WITH AN UNSPECIFIED MENTAL DISORDER) NOT BEING CORRECTLY AFFIXED ON THE SYSTEM PATIENT TABLE AND THE LACK OF PATIENT OBSERVATION DURING TABLE MOVEMENT. THIS IS NOT A PRODUCT QUALITY-RELATED ISSUE, AND THE SYSTEM WORKS AS SPECIFIED. THE ROOT CAUSE IS ATTRIBUTED TO USER ERROR.

    Description of Event or Problem · 0

    IT WAS REPORTED TO SIEMENS HEALTHINEERS THAT AFTER THE PATIENT WAS EXAMINED WITH THE SOMATOM EMOTION 16 SYSTEM, THE PATIENT HURRIEDLY GOT OFF THE SYSTEM PATIENT TABLE WHEN THE TABLE WAS STILL BEING MOVED DOWNWARDS RESULTING IN A FALL. THE PATIENT REPORTEDLY HAS AN UNSPECIFIED MENTAL DISORDER AND IN WAS IN THE COMPANY OF FAMILY DURING THE EXAMINATION. THE PATIENT WAS NOT FIXATED WITH STRAPS TO THE PATIENT TABLE (AS INDICATED IN THE SYSTEM INSTRUCTIONS FOR USE) DURING THE EXAMINATION. THE PATIENT¿S FALL RESULTED BRUISING OF THE SKIN ON THE PATIENT¿S FOREHEAD WHICH WAS TREATED BY A NURSE AT THE FACILITY. THE REPORTED INJURY WAS NOT SEVERE. HOWEVER, IN A WORST-CASE SCENARIO, THE LACK OF PATIENT FIXATION DURING AN EXAMINATION COULD RESULTS IN A SEVERE INJURY IF THE ISSUE WERE TO RECUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459864 SOMATOM EMOTION 16 (2007) SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK SIEMENS SHANGHAI, MEDICAL EQUIPMENT LTD. 10165977

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other