BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTIX IMPACT C

    MDR report key: 14427378 · Received May 18, 2022

    Report

    Report Number
    3003202425-2022-25425
    Event Type
    Injury
    Date Received
    May 18, 2022
    Date of Event
    April 21, 2022
    Report Date
    May 17, 2022
    Manufacturer
    SIEMENS SHANGHAI MEDICAL EQUIPMENT LTD
    Product Code
    KPR
    UDI-DI
    04056869262147
    PMA / PMN Number
    K203340
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE OPERATOR MANUAL, IT IS RESPONSIBILITY OF THE USER TO ENSURE THAT THE PATIENT HAND GRIPS ARE IN CORRECT POSITION AND DO NOT STAND IN THE WAY OF THE DETECTOR MOVING UP OR DOWN. IN THE REPORTED EVENT, THE OPERATOR DID NOT SWING THE HANDGRIP TO THE SIDE AS ADVISED IN THE MANUAL. THEREFORE, WHEN THE SCOLI EXAM WAS STARTED, THE HAND GRIP WAS NOT IN PROPER POSITION, WHICH LED TO THE HAND GRIP HITTING THE WALL STAND WORKSTATION AND DISLOCATING. THE STRETCH GRIP WAS CHECKED BY SIEMENS LOCAL SERVICE AND FOUND TO BE WITHIN SPECIFICATIONS. THE MULTIX IMPACT C SYSTEM WORKS AS INTENDED. SIEMENS IS NOT AWARE OF ANY SIMILAR INCIDENTS IN THE FIELD. INTERNAL ID # (B)(4).

    Description of Event or Problem · 0

    SIEMENS BECAME AWARE OF AN INCIDENT THAT OCCURRED ON THE MULTIX IMPACT C DEVICE. WHEN THE X-RAY TECHNICIAN WAS PREPARING FOR A SCOLI SERIES EXAMINATION AT THE WALL STAND, HE NEITHER REMOVED THE STRETCH GRIP NOR CHECKED WHETHER THE OVERHEAD HAND GRIP WAS FIRMLY ATTACHED TO THE WALL STAND. AS THE EXAMINATION BEGAN, THE STRETCH GRIP CAUGHT THE TOP OF THE MULTI PURPOSE ORTHO STAND CAUSING THE HANDLE TO BECOME LOOSE AND FALL FORWARD. THE PART FELL BUT MISSED THE PATIENT. THERE ARE NO INJURIES ATTRIBUTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1710888 MULTIX IMPACT C STATIONARY X-RAY SYSTEM KPR SIEMENS SHANGHAI MEDICAL EQUIPMENT LTD 11020896 04056869262147

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Female Other