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

Model Number	10848281
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported event.As this event is under investigation yet been determined.A supplement report will be filed if additional information becomes available.
Event or Problem Description
Siemens became aware of an incident that occurred while operating the artis q ceiling system.While moving the ceiling stand from the patient transfer position to the table, the clamp that holds the hose for the ceiling stand came off and almost hit a physician in the head.We have no indications of any adverse effects on the health status of the persons involved.
Additional Manufacturer Narrative
Siemens completed the investigation of the reported issue.The investigation was performed based on expert discussions considering complaint description, customer service reports, and system history, and system log files.According to the initial provided information, a hose clamp that supports the main cable bundle on the ceiling fell.No health consequences were reported to this event.The hose clamp consists of two similar halves that are connected by a screw.One of the halves of the clamp weighs less than 100 grams with a dimension of 167 mm by 120 mm by 30 mm.Therefore, serious injury from a falling clamp is not to be expected.Unfortunately, the investigation did not provide a clear picture of why or how the clamp loosened.As the cable hose clamps are not normally exposed to increased forces, according to expert opinion most likely the mounting screw of the clamp holding the hose has come loose due to external forces (i.E., collision) and the clamp has then fallen off.The operator manual contains adequate instructions regarding collision prevention.To resolve the problem, the clamp was replaced 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 incident described in the reported event is not classified as a reportable adverse event after a thorough investigation because neither serious injury, death, nor unexpected prolonged hospitalization of the patient or other person occurred or is to be expected, even if the incident recurs.H11 corrected data: h6: the medical device problem code reported in the initial mdr submitted on september 5, 2023, should have been 2907.Code 4004 was reported in error.H6: the medical device problem code reported in the initial mdr submitted on september 5, 2023, should have been 2907.Code 4004 was reported in error.

• Brand Name: ARTIS Q CEILING
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstrasse 1 or; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemensstrasse 1; or rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd., mc 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 17682051
• Report Number: 3004977335-2023-00104
• Device Sequence Number: 6281501
• 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): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2023

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: 08/23/2023
• Supplement Date Received by Manufacturer: 11/17/2023
• Initial Report FDA Received Date: 09/05/2023
• Supplement Report FDA Received Date: 11/20/2023
• 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