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

Model Number	10848354
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported events.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.
Event or Problem Description
It was reported to siemens that a malfunction occurred while operating the artis q.Zen ceiling system.The user reported that the accessory rail; complete with the mounted lead shield and control modules, came out and fell on the nurse's feet.At this time, there is no report of impact to the state of health of any patient or user involved.Siemens has requested additional information in order to conduct an investigation of the reported event.
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported events.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.
Event or Problem Description
It was reported to siemens that a malfunction occurred while operating the artis q.Zen ceiling system.The user reported that the accessory rail; complete with the mounted lead shield and control modules, came out and fell on the nurse's feet.At this time, there is no report of impact to the state of health of any patient or user involved.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 a user error.The investigation was performed considering complaint description, cs reports, system history, and cc-part.After a procedure, an operator moved the accessory rail on the table and the rail slid from the rail guide and fell together with the lead shield and some control modules on the floor.As a result, the rail hit the foot of a nurse.No health consequence was reported.The movement of the accessory rail is limited by the stop bracket that is fastened to the accessory rail and two bolts fastened to the rail guide.When the accessory rail is moved and the stop bracket hits one of the bolts, the movement is stopped to prevent the rail from sliding out of the rail guide.During an onsite intervention, siemens service found that the two bolts that keep the accessory rail from sliding out of the rail guide were missing.Since the bolts were missing, the accessory rail could slip out of the rail guide.The investigation revealed that the two threaded holes for the bolts were no longer round, but oval, and the screw threads that normally hold the two bolts were damaged.As a result, the bolts no longer held and fell off.Additionally, the stop bracket was damaged/deformed where it hits the bolts.This kind of damage indicates that the rail was frequently moved in such a way that the stop bracket hit the bolds with great force, causing them to finally fall off.The problem was resolved by replacing the accessory rail including the rail guide.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.After detailed investigation, the incident is not classified as a reportable event as neither serious injury, death nor an unexpected, prolonged hospitalization of the patient or any other person occurred or could be expected.

• Brand Name: ARTIS Q.ZEN CEILING
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH-AT; siemensstr. 1; forchheim, germany 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH-AT; siemensstr. 1; forchheim, germany 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; malvern, PA 19355 ; 4843231631
• MDR Report Key: 13412401
• Report Number: 3004977335-2022-14366
• Device Sequence Number: 3963100
• Product Code: OWB
• UDI-Device Identifier: 04056869010021
• UDI-Public: 04056869010021
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Remedial Action: Repair,Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2022

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: 10848354
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/26/2022
• Supplement Date Received by Manufacturer: 05/17/2022
• Initial Report FDA Received Date: 02/01/2022
• Supplement Report FDA Received Date: 05/18/2022
• 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
• Patient Sex: Unknown