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

Model Number 10849000

Device Problem No Apparent Adverse Event (3189)

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

Event Date 07/23/2021

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 artis pheno system.During an interventional procedure, the user reported a sudden dark screen on the large display.The procedure was continued and completed on an alternate system.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 has completed an investigation of the reported event.The root cause was determined to be a hardware error.The detailed investigation showed that the problem was due to a hardware defect.The optical transmitter for transferring the image data was defective.This was revealed by the examination at the factory.Such a defect can only be rectified by service intervention and replacement of the affected component.The affected component was replaced during service intervention and the system functions again as specified.The occurrence rate of the aforementioned error pattern and the spare parts consumption of the affected part were checked.A possible error accumulation or even a systematic error, which would lead to a corrective action 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: ARTIS PHENO
• 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: 12258358
• MDR Text Key: 264479490
• Report Number: 3004977335-2021-90476
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 04056869046877
• UDI-Public: 04056869046877
• Combination Product (y/n): N
• PMA/PMN Number: K201156
• 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: 08/02/2021

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: 10849000
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/24/2021
• Initial Date FDA Received: 08/02/2021
• Supplement Dates Manufacturer Received: 10/14/2021
• Supplement Dates FDA Received: 10/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1