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

Model Number 10143406

Device Problems No Device Output (1435); Radiation Output Problem (4026)

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

Event Date 03/31/2023

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 varic gen 2 mobile x-ray system.The user reported that they had to remove the mains power cable in order to stop fluoroscopy.As a result, patient treatment was terminated.We are unaware of any impact to the state of health of the patient or any user involved.Siemens has requested additional information in order to conduct an investigation of the reported event.

Manufacturer Narrative

The investigation was performed on expert discussions (considering complaint description, cs (customer service) reports, system history, system log files, cc-part analysis).The hand switch on the concerned unit was exchanged as part of the service activity.The error mentioned in the complaint has not reoccurred since the part replacement.The returned hand switch was examined in detail and showed no defect.The spare parts consumption of the hand switch was checked.Any accumulation of faults or even a possible general fault that would require corrective action of the installed base could not be determined.Furthermore, the investigation of the received dose reports revealed, the applied dose levels were in accordance with the system settings and imaging conditions, as well as the applicable regulatory requirements.No accidental radiation occurrence (aro) case even in the worst-case scenario could be identified.The problem claimed by the customer could not be confirmed by the investigation.However, it is difficult to recreate the situation described.In general, the customer is informed about active radiation release as the x-ray lamp flashes/illuminates, depending on configuration, and live x-ray images are displayed on the screen.

• Brand Name: ARCADIS VARIC GEN 2
• Type of Device: 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; forchheim, germany 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; malvern, PA 19355 ; 4843231631
• MDR Report Key: 16750136
• MDR Text Key: 313393071
• Report Number: 3004977335-2023-69209
• Device Sequence Number: 1
• Product Code: OXO
• UDI-Device Identifier: 04056869009018
• UDI-Public: 04056869009018
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K051133
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/14/2023

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: 10143406
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/31/2023
• Initial Date FDA Received: 04/17/2023
• Supplement Dates Manufacturer Received: 06/02/2023
• Supplement Dates FDA Received: 06/02/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1