MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH- AT ARCADIS ORBIC GEN 2; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE

Model Number	10143407
Medical Device Problem Code	Computer Operating System Problem (2898)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2021
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 arcadis orbic gen 2 system.During an interventional procedure, the user reported that the c-arm failed several times causing a delay in procedure.There is no report 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.
Additional Manufacturer Narrative
Siemens has completed an investigation of the reported event.The root cause was determined to be an operator error.The evaluation of the log files showed that the operator of the system very often used the sleep mode (hibernation mode) of the system, but without completely shutting down the system (rebooting), as required in the user manual.The previously mentioned hibernation mode is a special mode that allows the user to use the system again extremely quickly for urgent operations (e.G., emergency cases) without having to shut it down completely first.However, this mode cannot be used permanently, as it is also described accordingly in the user manual.The basic function is as follows: after the 10th hibernation mode via the off key, a dialog window opens, via which you can select the hibernation mode or the complete shutdown of the system.After the 15th hibernation mode via the off key, a complete shutdown is automatically performed with a corresponding notification to the user.This is a specified and described function.Although this can't be verified retrospectively, system experts agree that acting against the user manual, i.E., not shutting down the system completely, led to the working memory overfilling and ultimately caused the problem described in the complaint.This thesis is also supported by the fact that the error has not been reported since the customer agreed to the procedure described in the user manual and has since then completely switched off the system in the evening.The occurrence rate of the error pattern was checked.A possible error accumulation or even a systematic error that 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: ARCADIS ORBIC GEN 2
• Common Device Name: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE
• 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: 12459213
• Report Number: 3004977335-2021-95567
• Device Sequence Number: 3935621
• Product Code: OXO
• UDI-Device Identifier: 04056869009025
• UDI-Public: 04056869009025
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K051133
• 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
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2021

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/01/2021
• Supplement Date Received by Manufacturer: 11/12/2021
• Initial Report FDA Received Date: 09/13/2021
• Supplement Report FDA Received Date: 11/12/2021
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown