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

Model Number 10849000

Device Problem Mechanical Problem (1384)

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

Event Date 05/13/2021

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 that all movements were blocked.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.Assessment of the log files does not indicate a system failure or malfunction and no non-conformity was identified.According to the log files, movement of the system was possible at slow speeds in override mode.The technician went on site and performed troubleshooting; however, he could not find any defect and the system was running properly.Since the situation on site stabilized as a result of the service call and the original problem no longer existed, it was not possible to determine the cause of the fault.According to system specialists, it is conceivable that the proximity switch responsible for collision detection was activated for a short time, which was then rectified by the service intervention on site.The log file shows temporary actuation of the proximity switch, confirming this theory.Another indication of a temporary problem is that the system ran as specified after the on-site actions and no parts were replaced, nor could a defect be detected.The system has been tested successfully by the local service organization.The error has not been reported again.A possible general fault that would require corrective measures on the installed base could also 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; siemensstr. 1; forchheim, germany 91301 ; GM 91301
• MDR Report Key: 11884486
• MDR Text Key: 253262837
• Report Number: 3004977335-2021-80718
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 04056869046877
• UDI-Public: 04056869046877
• Combination Product (y/n): N
• PMA/PMN Number: K163286
• 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: 05/26/2021

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: 05/13/2021
• Initial Date FDA Received: 05/26/2021
• Supplement Dates Manufacturer Received: 07/12/2021
• Supplement Dates FDA Received: 07/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1