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 07/30/2021

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 system 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.The root cause was determined to be a user error.The investigation was performed considering complaint description, cs reports, system history, and system log files.During an interventional procedure, normal c-arm movement (normal speed, auto-drive) was blocked and the error message "collision of c-arm - move out of collision zone" was shown, although there was no actual collision.In this case, this meant that the c-arm of the system could no longer be moved at full speed, but only at reduced speed in so-called override mode for safety reasons.Although the imaging functionality was not affected the procedure was continued using an alternative system.During trouble shooting, as part of reactive service, there were no issues as described and the system works as intended.The logfile investigation shows an active proximity switch (limit switch for collision detection) of the "beam c-arm".According to our technical expert, the root cause is an improper mechanical deformation due to a collision or improper workmanship or liquid has penetrated the cover and triggered the proximity switch until it evaporated.A possible general 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 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: 12330278
• MDR Text Key: 266839340
• Report Number: 3004977335-2021-91262
• 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: 08/17/2021

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: 07/30/2021
• Initial Date FDA Received: 08/17/2021
• Supplement Dates Manufacturer Received: 10/28/2021
• Supplement Dates FDA Received: 10/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1