MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH- AT ARTIS ICONO BIPLANE; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number 11327600

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Hair Loss (1877)

Event Date 01/01/2021

Event Type  Injury  

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 an adverse event occurred following examination on the artis icono biplane system.A patient complained of hair loss approximately ten weeks after a neuro-coiling interventional procedure.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.Assessment does not indicate a system failure or malfunction and no non-conformity was identified.According to the complaint, some patients complained about hair loss months after their examination.Examination of the received log files showed that there was no malfunction of the system that could have led to the mentioned effect.In addition, system specialists went on site to clarify the situation and test the system.The applied dose levels were in accordance with the system settings and imaging conditions, as well as the applicable regulatory requirements.The system works as specified.Additional training was provided to the customer in that future working methods and settings could be found that allow a further reduction of the dose by the operator.A possible general system error, which would require corrective action of the installed base, could not be identified 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: ARTIS ICONO BIPLANE
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH- AT; siemensstrasse 1; forchheim, germany 91301 ; GM 91301
• MDR Report Key: 11580870
• MDR Text Key: 242679378
• Report Number: 3004977335-2021-72430
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 04056869063317
• UDI-Public: 04056869063317
• Combination Product (y/n): N
• PMA/PMN Number: K193326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 03/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 11327600
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other