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

Model Number 10143407

Device Problem Radiation Overexposure (3017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/05/2021

Event Type  malfunction  

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 Description

It was reported to siemens that a malfunction occurred while operating the arcadis orbic gen 2 system.In the regular annual testing performed by a third party, the result of the x-ray dose rate exceeds the limitation.There was no patient involvement during this testing.Siemens has requested additional information in order to conduct an investigation of the reported event.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.The root cause was determined to be a user error.The investigation showed that the error was not because of a malfunction of the system but because the system was not calibrated properly.Dose values can change with the aging of the system/components, e.G., single tank, image intensifier, generator, camera, usage of the system and environmental conditions.To compensate this aging, the system should be monitored by the user/operator and if it is detected that there is a drifting in the values, then calibrations can be done by siemens so that the system compensates those variations.In order to recognize the drifting, a monthly system check has to be done by the customer.How to do this is well described in the user manual on page 612.According to our onsite service team, the customer did not report any discrepency with the checks and dose values.Therefore, no calibration was done by our service team until the yearly test of a 3rd party failed.After informing the service team about the issue a service technician went on site and calibrated the system in order to get the correct dose values again.No malfunction has been recognized and no parts had to be exchanged.The system works as specified.The occurrence rate of the above-mentioned fault pattern has been checked and 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: ARCADIS ORBIC GEN 2
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH-AT; siemensstr. 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: 13042749
• MDR Text Key: 285826160
• Report Number: 3004977335-2021-08012
• Device Sequence Number: 1
• Product Code: OXO
• UDI-Device Identifier: 04056869009025
• UDI-Public: 04056869009025
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K051133
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 12/20/2021

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
• Device Operator: Health Professional
• Device Model Number: 10143407
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/05/2021
• Initial Date FDA Received: 12/20/2021
• Supplement Dates Manufacturer Received: 01/24/2022
• Supplement Dates FDA Received: 01/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1