MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH AXIOM LUMINOS AGILE; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM

Model Number	10094200
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The described situation may occur if service technician does not lock the safety lock of the spring pulley before replacing the spring pulley, as indicated in service documentation.In this case the overhead column may move upwards with high speed and high force as soon as the last screw is detached from the tube assembly.Since the reported issue can occur only under service conditions, there is no risk of patient or operator involvement.The investigation is on-going.A supplemental report will be submitted if additional information becomes available.Internal id # (b)(4).
Event or Problem Description
Siemens local service engineer reported that when performing a spring pulley replacement on the axiom luminos agile system, he discovered that the casting was cracked following the service.There was no patient involvement in this case.No injuries are attributed to this event.
Additional Manufacturer Narrative
The issue was investigated in detail.According to the description of the issue, the casting of the tube stand was found broken during service.The provided photos were analyzed by system experts.The analysis showed that during the service the spring pulley was replaced but it was forgotten to lock the pulled-out tube against moving up.As soon as the tube arm was detached from the tube, it would shoot up due to the tension of the spring until it would hit the stop.This would cause the casting to break as happened in this case.The local service technician was informed of this matter; he confirmed that the lock had been opened in order to be able to use the screw for the fall protection of the spring pulley.The handling of the exchange is described in the document (b)(4) (replacement spring pulley).The affected part was already replaced at customer site.No system malfunction was identified, the system works as specified.

• Brand Name: AXIOM LUMINOS AGILE
• Common Device Name: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd.; mc 65-1a; malvern, PA 19355 ; 6104486478
• MDR Report Key: 12691147
• Report Number: 3004977335-2021-01519
• Device Sequence Number: 12983653
• Product Code: JAA
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K111292
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2021

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
• Operator of Device: Health Professional
• Device Model Number: 10094200
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2021
• Supplement Date Received by Manufacturer: 02/10/2022
• Initial Report FDA Received Date: 10/25/2021
• Supplement Report FDA Received Date: 02/25/2022
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown