MAUDE Adverse Event Report: SIEMENS HEALTHINEERS AG LUMINOS AGILE MAX; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number	10762472
Medical Device Problem Codes	Disconnection (1171); Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Siemens healthineers was made aware of a potential product problem involving the luminos agile max system.During service activities the service engineer noticed that the cylinder screw (bolt) in the shaft which connects the monitor support arm (dcs) to the carriage was missing.There was no patient or user injury associated with this finding.The dcs was still in place.It is assumed that in a worst-case scenario, if the support arm had been used further without noticing the issue, the issue might have led to a serious injury by large parts falling and hitting a person.
Additional Manufacturer Narrative
E1: a facility contact name was not provided for reporting purposes.The issue was discovered during a service activity by a siemens healthineers customer service engineer.H3, h6: initial corrective actions/preventive actions implemented by the manufacturer: an additional instruction document for new installations of the dcs/dws was released on may 7, 2024.Manufacturers preliminary analysis: the reason for the missing bolt is under investigation.The root cause has not yet been determined.Siemens healthineers will submit a supplemental report if additional information is obtained upon completion of the investigation.
Additional Manufacturer Narrative
B5: additional information.H3, h6: the investigation of the installation issue for both the bolt and the unconnected ground wire are ongoing.The cylinder screw was replaced, and the grounding wire was connected.A supplemental report will be submitted to the fda upon completion of the investigation.
Event or Problem Description
Additional information: siemens healthineers received additional information regarding an installation problem at the customer site.On 2024-06-14, the siemens customer service engineer (cse) visited the customer site to install the missing cylinder screw, he noticed that the grounding wire for the boom arm trolley was not attached.The risks associated with this issue were evaluated on 2024-06-20.No injuries occurred at the customer site due to this second installation issue.It is assumed that in a worst-case scenario, if there had been an electrical fault within the dcs, the unconnected grounding wire might have led to a potentially fatal electrical shock.Currently, siemens healthineers has not been made aware of any injury associated with an unconnected ground wire in the display ceiling stand.

• Brand Name: LUMINOS AGILE MAX
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHINEERS 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: rebecca tudor ; 40 liberty blvd., mc 65-1a; malvern, PA 19335 ; 4843234198
• MDR Report Key: 19369726
• Report Number: 3004977335-2024-00055
• Device Sequence Number: 7528871
• Product Code: OWB
• UDI-Device Identifier: 04056869009162
• UDI-Public: 04056869009162
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K173639
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2024

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: Other
• Device Model Number: 10762472
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2024
• Supplement Date Received by Manufacturer: 06/14/2024
• Initial Report FDA Received Date: 05/22/2024
• Supplement Report FDA Received Date: 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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