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

Model Number	10848282
Medical Device Problem Code	Radiation Output Failure (4027)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2022
Type of Reportable Event	Malfunction
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 a malfunction occurred while operating the artis q bipane system.During an interventional procedure, the user reported receiving an a-plane too hot error message.The procedure was continued and completed on an alternate system.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.
Additional Manufacturer Narrative
Siemens conducted a detailed investigation of the reported event.The investigation was performed on expert discussions (considering complaint description, cs reports, system history, system log files).The detailed investigation revealed that the cause of the blocked x-ray release was a temporary problem in the internal signal processing.In regular intervals the hardware is checked automatically.Within this check the signal line between relevant sensors and the evaluation component is tested.The test is triggered when a relay switches the contact to the sensors off and back on.The d1-board (evaluation component) detects the falling edge and checks that the voltage drops below a defined "low" level and remains like that for a defined, short period of time.In the present case, it was found that the contact of the relay showed bounce effects/voltage fluctuations.This triggered multiple, successive falling edges that repeated the cable test.However, since the voltage must remain in the "low" state for a certain time for the test to pass, this caused the test to fail even though there was no fault on the signal line.As a result, the x-ray release was prevented for plane a to avoid possible severe damage to the x-ray tube.In this case the error occurs in plane a of a biplane system, x-ray will be blocked in plane a and bypass mode will be activated, which leads to blocking x-ray in plane b.Normal operation of the system was restored by a "power cycle," i.E., the system was shut down and turned back on so that the associated components (x-ray generator, tube) were restored to normal.Field update (ax028/22/s, ax039/22/s) was triggered for this sporadic problem and will be reported separately if necessary.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.The corresponding probability according to the risk analysis is in the range of inconceivable.

• Brand Name: ARTIS Q BIPLANE
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH-AT; siemensstr. 1; forchheim, germany 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH - AT; siemensstr. 1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 14693392
• Report Number: 3004977335-2022-30454
• Device Sequence Number: 15105350
• Product Code: OWB
• UDI-Device Identifier: 04056869009995
• UDI-Public: 04056869009995
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• 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
• Initial Reporter Occupation: Other
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2022

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?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2022
• Supplement Date Received by Manufacturer: 08/29/2022
• Initial Report FDA Received Date: 06/15/2022
• Supplement Report FDA Received Date: 08/31/2022
• 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
• Patient Sex: Unknown