BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTIS Q BIPLANE

    MDR report key: 6809538 · Received August 22, 2017

    Report

    Report Number
    3004977335-2017-92456
    Event Type
    Injury
    Date Received
    August 22, 2017
    Date of Event
    July 17, 2017
    Report Date
    August 15, 2017
    Manufacturer
    SIEMENS HEALTHCARE GMBH
    Product Code
    OWB
    PMA / PMN Number
    K123529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2017017. (B)(4). 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 · 0

    IT WAS REPORTED TO SIEMENS THAT AN ADVERSE EVENT OCCURRED WHILE OPERATING THE ARTIS Q BIPLANE SYSTEM. DURING PREPARATIONS FOR A PEDIATRIC PROCEDURE, THE TABLE WAS BEING ROTATED INTO AN INTERVENTIONAL POSITION. THE TABLE ROTATION BRAKES WERE APPLIED WHILE CONTINUING TO PUSH THE TABLE, CAUSING THE TABLE MATTRESS TO SLIDE AT THE HEAD END OF THE TABLE. AS A RESULT, THE PEDIATRIC PATIENT FELL TO THE FLOOR AND SUFFERED A SKULL FRACTURE. THE PEDIATRIC PATIENT RECEIVED A CT SCAN AND MR EXAM FOLLOWING THE EVENT. WE ARE UNAWARE OF ANY FURTHER MEDICAL TREATMENT OR IMPACT TO THE PATIENT INVOLVED.

    Additional Manufacturer Narrative · 1

    SIEMENS HAS COMPLETED AN INVESTIGATION OF THE REPORTED EVENT. ASSESSMENT OF THE LOG FILES DOES NOT INDICATE A SYSTEM FAILURE OR MALFUNCTION AND NO NON-CONFORMITY WAS IDENTIFIED. INSTRUCTIONS FOR PROPER USE TO SECURE THE PATIENT DURING EXAMINATION ARE PROVIDED WITH THE SYSTEM IN THE FOLLOWING DOCUMENT: "OPERATOR MANUAL VOLUME 1, SAFETY, TECHNICAL AND ADMINISTRATIVE INFORMATION "SYSTEM OPERATION", WARNING "MOVEMENT OF THE PATIENT ON THE TABLETOP" THE TABLE TOP IS NOT DESIGNED TO PREVENT A PATIENT FROM FALLING WHEN NOT FASTENED AS DESCRIBED IN THE USER MANUAL. THE WHOLE PROCESS OF PATIENT FIXATION IS UNDER THE RESPONSIBILITY OF THE OPERATOR. THAT INCLUDES THE TABLE TOP, THE MATTRESS, FIXATION ACCESSORIES, THE ALIGNMENT OF THE MATERIAL AND THE PATIENT ON THE TABLE AND A PROPER EXECUTION OR FIXATION PERFORMED BY THE OPERATOR INCLUDING SPENDING APPROPRIATE ATTENTION TO THE PATIENT DEPENDING E.G. HIS RESPONSE ABILITY. THEREFORE, THERE IS NO INDICATION OF A SYSTEM MALFUNCTION AND THIS EVENT IS CONSIDERED TO BE A USER ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590799 ARTIS Q BIPLANE INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SIEMENS HEALTHCARE GMBH 10848282

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization