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

Model Number	10764561
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens has initiated a detailed investigation of the reported event.A root cause has not yet been identified.Siemens will submit a supplemental report with the results of the investigation when it has been completed.
Event or Problem Description
It was reported to siemens that a malfunction occurred when using the sensis system.During an interventional procedure, the system had no connection to the integrated signal input box (activation failure).The procedure was continued and finished using an alternate system.Siemens has not been made aware of any adverse health effects to the involved patient.The reported event occurred in (b)(6).
Additional Manufacturer Narrative
Siemens has completed an investigation of the reported event.The root cause was determined to be a hardware error.The detailed investigation showed that the problem was due to a hardware error.The system was unable to establish a connection to the integrated signal input box (isib), which meant that patient registration was also not possible.A restart brought no improvement and thus no examination could be started.Only an on-site service intervention provided a remedy.A circuit board of the real time controller (rtc) was exchanged.The replaced and returned rtc pc ((b)(4)) board was examined at the factory and showed an error during autostart of the application.After replacement of the part on site, the system was running again as specified.The occurrence rate of the mentioned error pattern and the spare part consumption of the affected part was checked.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: SENSIS
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH - AT; siemensstrasse 1; forchheim, 91301 ; GM 91301
• MDR Report Key: 12255852
• Report Number: 3004977335-2021-90949
• Device Sequence Number: 3635225
• Product Code: OWB
• UDI-Device Identifier: 04056869010137
• UDI-Public: 04056869010137
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K150493
• 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: Repair,Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2021

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
• Operator of Device: Health Professional
• Device Model Number: 10764561
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/28/2021
• Supplement Date Received by Manufacturer: 10/14/2021
• Initial Report FDA Received Date: 07/30/2021
• Supplement Report FDA Received Date: 10/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1