MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH-AT ARCADIS VARIC GEN2; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE

Model Number	10143406
Medical Device Problem Code	Radiation Output Failure (4027)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2022
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 arcadis varis gen 2 system.During surgery, the user reported that no x-ray was possible and an error message was shown.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, customer service reports, and system history).According to the trinidad hospital report, the procedure was delayed because the x-ray could not be exposed.The hospital contracted the independent service company, semes, who is not a partner of siemens hs mexico, to troubleshoot the system.According to the semes service report there were communication problems between the c-arm and the trolley.It was determined that there was a contact fault in the sg cable.The problem was fixed by the replacement of the affected cable.The error has not again been reported since then.The occurrence rate of the aforementioned error pattern was checked.A possible error accumulation or even a systematic error, which leads to a corrective action of the installed base, could not be determined by the investigation.The incident described in the adverse event is not classified as a reportable event after a thorough investigation because neither serious injury, death, nor unexpected prolonged hospitalization of the patient or other person occurred or is to be expected, even if the incident recurs.Internal id# (b)(4).

• Brand Name: ARCADIS VARIC GEN2
• Common Device Name: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH-AT; siemensstr. 1- or-; rittigfeld 1; forchheim, germany 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH-AT; siemensstr. 1 or rittigfeld 1; rittigfeld 1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 15182193
• Report Number: 3004977335-2022-37393
• Device Sequence Number: 17594525
• Product Code: OXO
• UDI-Device Identifier: 04056869009018
• UDI-Public: 04056869009018
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K051133
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2022

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: 10143406
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/14/2022
• Supplement Date Received by Manufacturer: 09/23/2022
• Initial Report FDA Received Date: 08/08/2022
• Supplement Report FDA Received Date: 09/26/2022
• 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