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

Model Number 10143406

Device Problems Fracture (1260); Unintended Collision (1429); Use of Device Problem (1670)

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

Event Date 02/23/2023

Event Type  malfunction  

Event Description

Siemens became aware of an incident that occurred while operating the arcadis varic gen 2 system.During a patient procedure the user lowered the table while the system (c-arm) was still underneath.As a result of the collision the image intensifier was bent.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.

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.

Manufacturer Narrative

The investigation of the reported incident was completed.Normal system operation was recovered by service intervention.The image intensifier on the concerned unit was replaced.The investigation found no evidence of a system malfunction that would have caused the collision.The collision was due to a user error.The operator manual contains adequate instruction about handling the system with regards to the risk of collision.

• Brand Name: ARCADIS VARIC GEN2
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH-AT; siemenstrasse 1 or; rittigfeld 1; forchheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH-AT; siemenstrasse 1 or; rittigfeld 1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: anastasia sokolova ; liberty blvd 40; mc 65-1a; malvern, PA 19355 ; 4843234897
• MDR Report Key: 16502203
• MDR Text Key: 310955175
• Report Number: 3004977335-2023-65059
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K051133
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/08/2023

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?: Yes
• Initial Date Manufacturer Received: 02/23/2023
• Initial Date FDA Received: 03/08/2023
• Supplement Dates Manufacturer Received: 03/20/2023
• Supplement Dates FDA Received: 03/21/2023
• 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