MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH AXIOM ARTIS DTA; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number 7008605

Device Problem Use of Device Problem (1670)

Patient Problems Concussion (2192); Injury (2348)

Event Date 01/05/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 an adverse event occurred while operating the axiom artis dta system.It was reported that the cable trolley fell out of the display ceiling suspension rail and injured the operator.The operator was admitted to the emergency room for evaluation and diagnosed with a concussion.There is no report of impact to the state of health of any patient involved.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.The root cause was determined to be a hardware error.The investigation showed that a defective fiber wheel of the cable trolley caused the error mentioned in the complaint.The returned part has been examined by the supplier; however, the investigation could not clarify the exact cause of the defect.According to specialists, the most plausible reason for the error is repeated extraordinary mechanical collisions with obstacles that damaged the cable carrier and finally resulted in the wheel slipping out of the mounting bracket.The "instruction for use" contains information about system movements and the prevention of collisions.The spare parts consumption of the fiber wheel has been checked and found far below threshold and a systematic problem has not been discovered.The affected part has been exchanged by the local service organization and the error did not reoccur.The manufacturer is not considering further actions resulting from this event as no systematic error has been recognized.

• Brand Name: AXIOM ARTIS DTA
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forccheim, germany 91301 ; GM 91301
• MDR Report Key: 8482679
• MDR Text Key: 140905162
• Report Number: 3004977335-2019-63801
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• PMA/PMN Number: K052202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 01/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 7008605
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/07/2019
• Event Location: Hospital
• Date Report to Manufacturer: 01/07/2019
• Date Manufacturer Received: 03/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization