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

Model Number	10848282
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to siemens that a malfunction occurred while operating the artis q biplane system.The user reported that during an interventional procedure all motor movements were blocked.The procedure was completed on an alternate unit.At this time, we have no indication of 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.The reported event occurred in (b)(6).
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.Internal id # (b)(4).
Additional Manufacturer Narrative
Siemens conducted a detailed investigation of the reported event.The investigation was performed on expert discussions (considering complaint description, cs (customer service) reports, system history, system log files and c-part).During an interventional procedure, the normal c-arm movement (normal speed, autodrive) was blocked and the error message "reduced stand/table speed, sc" and "limited stand/table movement, sc" was displayed.The investigation revealed that the proximity switch on the outer side of the c-arm was permanently activated due to a mechanical defect.As a result, movement of the system was only possible in override mode at reduced speed.The operator manual contains adequate instructions for the safe operation of the system in this failure scenario.The exchange of the proximity switch solved the problem.To determine the reason for the switch problem, several simulations were carried out in the laboratory.The most likely cause is an improper handling of the system, which led to a mechanical load (e.G.Collision with unknown obstacle) on the proximity switch and finally to the described problem.The log file as well as the analysis of the defective proximity switch confirmed a collision with an unknown object due to a user error is the most likely root cause.The incident described was not classified as a reportable adverse event after detailed investigation, because neither serious injury, death nor an unexpected, prolonged hospitalization of the patient or any other person occurred or could be expected, even if the event recurs.A potential general fault that would require corrective measures of the installed base could not be determined by the investigation.Internal id # (b)(4).

• Brand Name: ARTIS Q BIPLANE
• Common Device Name: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH-AT; siemensstr. 1 or rittigfeld 1; forchheim 91301
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.; mc 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 14601588
• Report Number: 3004977335-2022-29403
• Device Sequence Number: 5064931
• Product Code: OWB
• UDI-Device Identifier: 04056869009995
• UDI-Public: 04056869009995
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2022

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
• Operator of Device: Health Professional
• Device Model Number: 10848282
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2022
• Supplement Date Received by Manufacturer: 09/20/2022
• Initial Report FDA Received Date: 06/06/2022
• Supplement Report FDA Received Date: 09/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown