MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH ARTIS Q CEILING; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM

Model Number	10848281
Medical Device Problem Codes	Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported event.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.Internal id # (b)(4).
Event or Problem Description
It was reported to siemens that a malfunction occurred while operating the artis q ceiling system.A display ceiling suspension fell out of the tracks and was found on the floor.No persons were involved in the reported incident.Siemens has requested additional information in order to conduct an investigation of the reported event.
Additional Manufacturer Narrative
Siemens has completed an investigation of the reported event.The root cause was determined to be an individual work error.At the end of a procedure, the display ceiling suspension (dcs) carriage was moved by the operator towards the patient's foot end.The ceiling carriage is used to move the entire ceiling pendant, including the monitor.To do this, the user manually pulls the dcs into the desired position.If the dcs is pulled to the end of the rails it is stopped by a mechanical end stop.In the given case, this mechanical end stop was not attached correctly, which ultimately caused the ceiling carriage to slip out of the rails on this side.Only the front rollers left the rails and the other rollers remained in the rails.Therefore, the carriage did not fall completely to the floor, but the carriage tilted due to gravity and bent the carriage.No one was injured in the given event.In this condition, the system is no longer operational and service intervention is necessary to repair the dcs.The cause for the incident was found to be two completely loose allen screws and two loose allen-head set screws that fix the end stop.However, it could not be determined why the screws were not tight.No anomalies were found during the review of the installation protocol dated 01/17/2016.Unfortunately, the maintenance protocols could not be reviewed because the customer performs the maintenance themselves and refused to provide the protocols.The maintenance instructions explicitly state to check that the end stops are mounted correctly.Both the on-site investigation and the detailed investigation at the factory revealed that this was neither a design problem nor a systematic problem.The occurrence rate of the error pattern was checked.A possible error accumulation or even a systematic error, which would lead to a corrective action of the installed base, could not be determined by the investigation.

• Brand Name: ARTIS Q CEILING
• Common Device Name: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1 or; rittigfeld 1; forchheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH-AT; siemensstr. 1- or-; rittigfeld 1; forchheim, germany 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; mc 65-1a; malvern, PA 19355 ; 4843231631
• MDR Report Key: 15282639
• Report Number: 3004977335-2022-40401
• Device Sequence Number: 2328834
• Product Code: OWB
• UDI-Device Identifier: 04056869009988
• UDI-Public: 04056869009988
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection,Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2022

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: 10848281
• 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: 08/15/2022
• Supplement Date Received by Manufacturer: 11/11/2022
• Initial Report FDA Received Date: 08/24/2022
• Supplement Report FDA Received Date: 11/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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