MAUDE Adverse Event Report: SIEMENS HEALTHINEERS AG ARTIS ZEE FLOOR; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number	10094135
Medical Device Problem Codes	Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Unspecified Tissue Injury (4559); Insufficient Information (4580)
Date of Event	03/12/2024
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.Section h6 code 4755 - counterweight.
Event or Problem Description
Siemens became aware of an incident that occurred while operating the artis zee floor unit.During movement of the dcs (display ceiling suspension), the counterweight fell down and hit the operator.Health status of the operator is currently unknown.Siemens requested additional information regarding this event.
Additional Manufacturer Narrative
The investigation of the reported event was completed by our experts.The counterweight of the display ceiling suspension (dcs) became loose and fell to the floor.After the initial impact with the floor, the weight tipped over and hit one of the employees on the foot, breaking the toenail of the pinky toe.The counterweights are installed at the system behind the monitors to ensure the balancing of the dcs support arm.The proper fastening of the set screws and slot nuts is checked during the pre-assembling in the factory and during the maintenance services.Siemens is unaware of similar events in the field as the report incident is the first-time occurrence.According to the experts, however, loose screws and/or slot nuts were most likely the cause of the counterweight detachment.The root cause of how or why the screws and slot nuts became loose could not be determined.The counterweight on the concerned unit was reinstalled and torqued properly according to the factory specifications as part of service activity.The occurrence rate of the aforementioned 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 primary udi number is section d4 was corrected.

• Brand Name: ARTIS ZEE FLOOR
• 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: anastasia sokolova ; 40 liberty blvd; malvern, PA 19355 ; 4843234197
• MDR Report Key: 19071637
• Report Number: 3004977335-2024-00040
• Device Sequence Number: 4732614
• Product Code: OWB
• UDI-Device Identifier: 04056869010045
• UDI-Public: (01)04056869010045(21)135791
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K181407
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2024

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: 10094135
• 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: 03/12/2024
• Supplement Date Received by Manufacturer: 07/17/2024
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 07/18/2024
• 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