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

Model Number 10848282

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/20/2021

Event Type  Injury  

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 Description

It was reported to siemens that a malfunction occurred while operating the artis q biplane system.During an emergency procedure, the user reported that the system suddenly turned off by itself.We are unaware of any impact to the state of health of the patient involved.Siemens has requested additional information in order to conduct an investigation of the reported event.

Manufacturer Narrative

At this time, no investigation result can be given as the information communicated to siemens healthcare contains different statements regarding the issue.As an interim result, it could be determined that the flat detector (fd) received a downward motion request, which was executed by the fd.A short collision was also subsequently detected by the system.Available data is currently being analyzed and a final report will be filed upon completion of the investigation.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.Assessment does not indicate a system failure or malfunction and no non-conformity was identified.The investigation was performed considering complaint description, cs reports, system history, and system log files.The user describes that the system hit the abdomen of a patient and triggered the collision protection.Further system movements of the c-arm or table were blocked so that the patient could not be freed immediately.The system was switched on and off several times in order to be able to perform movements again and free the patient.Based on the available log files, the following temporal events occurred.A downward movement of the flat detector (fd) movement was activated and executed.During this movement, the collision detection was activated, which immediately stopped the movement (safety measure).The collision protection was activated for 1 second.This means that the collision was immediately resolved and further movements were possible.After about 4 minutes, the table rotation was activated, which was directly interrupted by a power cut.This aborted all system actions.After about 5 minutes, the system was started up again.A repeated switching off and on of the system cannot be confirmed.An activation of the "emergency power off" could be determined as the cause of the power cut.The "emergency power off" button is installed on site and switches the system totally off, if pressed.Restarting the system was only possible after resetting the "emergency power off".A power cut-off could be determined as the cause for the blockage of system movements.How and why this "emergency power off" was pressed could not be determined.Based on the available information, there is no fault in the siemens system.The system operated as specified.The safety measures of the collision protection are active and effective.A possible error accumulation or even a systematic error, which would lead to a corrective action of the installed base, could not be determined by the investigation.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 BIPLANE
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH- AT; siemensstrasse 1; forchheim, germany 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH-AT; siemensstr. 1; forchheim, germany 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; malvern, PA 19355 ; 6104486461
• MDR Report Key: 12432358
• MDR Text Key: 272168203
• Report Number: 3004977335-2021-94597
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 04056869009995
• UDI-Public: 04056869009995
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K181407
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup,Followup
• Report Date: 09/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10848282
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/25/2021
• Initial Date FDA Received: 09/07/2021
• Supplement Dates Manufacturer Received: 10/28/2021; 11/17/2021
• Supplement Dates FDA Received: 10/28/2021; 11/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1