MAUDE Adverse Event Report: SIEMENS HEATHINEERS AG ARTIS PHENO; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number	10849000
Medical Device Problem Code	Unintended Collision (1429)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported event.A supplement report will be filed if additional information becomes available.H6 4755 - slide gantry.
Event or Problem Description
Siemens became aware of an incident that occurred while operating the artis pheno system.During a routine preoperative system preparation, communication between the digital substruction angiography (dsa) and the slide gantry was lost.This failure resulted in a collision between the unit and the slide gantry.We are unaware on any adverse effects on the health status of the involved persons, however, this incident resulted in a procedure delay.
Additional Manufacturer Narrative
The investigation was completed with the following result.Despite several attempts to collect additional information, the requested data was not provided.Further investigation regarding the communication issue between the artis pheno system and the slide gantry cannot be conducted without the log files.Based on the available information, it is assumed the collision was caused by a user error.The operator manual contains adequate instructions on how to move the system.It is the responsibility of the operator to ensure that unit movements are released only if it is certain that neither the operator, the patient, third parties nor other pieces of equipment can be endangered by these movements.The occurrence rate of the error pattern was checked.A possible error accumulation or even a systematic error, which leads to a corrective action of the installed base, could not be determined by the investigation.The incident described in the adverse event was not classified as a reportable event after detailed investigation, because neither serious injury, death nor an unexpected prolonged hospitalization of the patient or any other person occurred or could be expected, since the corresponding probability according to the risk analysis is in the range of inconceivable.

• Brand Name: ARTIS PHENO
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEATHINEERS AG; siemensstrasse 1 or; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHINEERS AG; siemensstrasse 1 or; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd.; malvern, PA 19355 ; 4843234197
• MDR Report Key: 18476340
• Report Number: 3004977335-2024-00171
• Device Sequence Number: 6794359
• Product Code: OWB
• UDI-Device Identifier: 04056869046877
• UDI-Public: 04056869046877
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K201156
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2024

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
• Operator of Device: Health Professional
• Device Model Number: 10849000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2024
• Supplement Date Received by Manufacturer: 03/18/2024
• Initial Report FDA Received Date: 01/09/2024
• Supplement Report FDA Received Date: 03/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown