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

Model Number 10143406

Device Problem Unintended Collision (1429)

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

Event Date 08/25/2021

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 varic gen 2 system.During a surgical procedure, the user reported that the c-arm horizontal could not be locked and there was a collision with the patient.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.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.The root cause was determined to be a hardware error.This complaint was reported because we received the initial message that a collision with the patient had occurred.Inquiries with the customer revealed that this was not the case and there was no collision with the patient.During the on-site service intervention, no parts were exchanged that could have been sent to the factory for investigation.Therefore, the investigation is mainly based on the opinion of our system experts, based on the available data.According to the local service department, the so-called "guide wheel drive shaft" was fixed on site and the system was then subjected to a system test.After that, the system was running perfectly again.The occurrence rate of the error pattern of the affected part was checked.A possible accumulation of faults or even a systematic fault that would lead to a corrective measure 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 VARIC GEN 2
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH- AT; siemensstrasse 1; forchheim, germany 91301 ; GM 91301
• MDR Report Key: 12406284
• MDR Text Key: 272170902
• Report Number: 3004977335-2021-94590
• Device Sequence Number: 1
• Product Code: OXO
• UDI-Device Identifier: 04056869009018
• UDI-Public: 04056869009018
• Combination Product (y/n): N
• PMA/PMN Number: K051133
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2021
• 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
• Date Manufacturer Received: 10/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1