MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH ARTIS Q FLOOR; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number	10848280
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Unspecified Musculoskeletal problem (4535)
Date of Event	04/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported to siemens that an adverse event occurred while operating the artis q floor system.The user reported that a nurse suffered an injury during c-arm movement which required stitches.There is no report of further 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.
Additional Manufacturer Narrative
Siemens has completed an investigation of the reported event.The root cause was determined to be a user error.After a procedure, during cleaning and preparation activities for the next procedure, a person leaned over the control modules on the table and accidentally pressed with her body the activation button for the c-arm on the joystick and at the same time deflected the joystick.As a result, the c-arm started to move, and the c-arm hit one of the nurses at the shin causing a laceration.The operator manual contains adequate instructions about system movement and how the operator can avoid a collision: all unit movements are controlled with a dead man's grip (dmg).C-arm movement is only possible if the button on top of the joystick (dmg-button) is pressed while the joystick is deflected at the same time.After releasing the dmg-button the movement is immediately stopped.Only deflecting the joystick without additionally pressing the dmg-button does not result in c-arm movement.During cleaning and preparation activities the system movement and radiation release should be blocked by pressing the appropriate buttons on the examination control console (ecc) or the software buttons (in control room).In addition, the movement is automatically stopped if a proximity switch of the system collides with an object or person.In this case the log file shows that the proximity switch of the collimator stopped the movement of the c-arm and prevented further harm as intended.Assessment does not indicate a system failure or malfunction and no non-conformity was identified.The system works as specified.After detailed investigation, the incident is not classified as a reportable event as neither serious injury, death nor an unexpected, prolonged hospitalization of the patient or any other person occurred or could be expected.

• Brand Name: ARTIS Q FLOOR
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstr. 1; forchheim, germany 91301 ; GM 91301
• MDR Report Key: 11797984
• Report Number: 3004977335-2021-77637
• Device Sequence Number: 11729665
• Product Code: OWB
• UDI-Device Identifier: 04056869009971
• UDI-Public: 04056869009971
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K181407
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 10848280
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/21/2021
• Supplement Date Received by Manufacturer: 05/20/2021
• Initial Report FDA Received Date: 05/10/2021
• Supplement Report FDA Received Date: 05/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other