MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH - AT ARCADIS OBRIC GEN2; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number	10143407
Medical Device Problem Code	Radiation Output Problem (4026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporting facility phone number is: (b)(6).Siemens is conducting a thorough investigation of the reported event.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 before a patient procedure the footswitch was malfunctioning frequently.Sometimes the system had no reaction after depressing the footswitch and sometime exposure was triggered automatically without depressing the footswitch.There was no patient involvement.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 cable of the foot switch was defective.Since the customer declined the on-site service visit, neither log files nor the affected part were available for the investigation.The investigation is therefore based on the data currently available.According to information from the regional service organization, the customer refused repair by siemens; the customer took care of repairing the cable himself.Further details on the root cause would require a more in-depth analysis of the log files and an examination of the defective part.Unfortunately, neither of these is possible for the reasons mentioned above.A possible general error, which would require corrective measures of the installed base, could not be determined by the investigation.The incident described in the adverse event was not classified as a reportable 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, since the corresponding probability according to the risk analysis is in the range of inconceivable.

• Brand Name: ARCADIS OBRIC GEN2
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH - AT; siemensstrasse 1; forchheim, 91301 ; GM 91301
• MDR Report Key: 11060964
• Report Number: 3004977335-2020-59062
• Device Sequence Number: 2586192
• Product Code: OWB
• UDI-Device Identifier: 04056869009025
• UDI-Public: 04056869009025
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K042793
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2021

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: 10143407
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/08/2020
• Supplement Date Received by Manufacturer: 01/21/2021
• Initial Report FDA Received Date: 12/22/2020
• Supplement Report FDA Received Date: 01/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1