MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH- AT ARTIS ZEE BIPLANE MN; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number	10094143
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	09/09/2020
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 zee biplane mn system.The user reported that the ceiling arm had fallen out of the support rails.The event did not occur during a patient procedure, and 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 human error.The incident occurred with a monitor support system that is mounted to the ceiling in a movable manner by means of castors.Several monitors are fixed to the monitor support system with a device on a movable support arm.This support arm in turn hangs on a ceiling carriage between two parallel rails on the ceiling, which makes it possible to move the monitors to the position desired by the customer, within the room.To mount the ceiling rail system, a total of 28 retaining screws (7 pairs / 14 pieces per ceiling rail) with a defined torque are used for fastening.In the given case, the monitors were found on the floor together with the support system.According to the information provided, the incident happened at night and not during an investigation.During a thorough inspection of the ceiling rail system, loose retaining screws were found on one of the two rails.Of the 14 retaining screws, eight were completely loosened and could be unscrewed without the use of a tool.In addition, four further retaining screws did not correspond to the defined torque and only two, which were located at the end of the rail system, fulfilled the defined torque.As a result, the rollers of the mobile ceiling carriage could jump out of their guide, which ultimately resulted in the incident reported.The torque of the retaining screws on the entire second rail complied with the specification.Further investigation, in particular the maintenance report dated 2019-10-13, showed that the retaining screws had been checked and had the required torque on that date.It can be assumed that the retaining screws were not loosened until a later time.As no service work has been carried out by siemens healthineers in this area since then, it can be assumed that these retaining screws were loosened by third parties for reasons unknown to us.It is of concern that only one rail (see above - execution of the on-site inspection), namely the one facing the ventilation system, was loose, but the other rail was tight as described.It is no longer possible to determine when, by whom and why these screws were loosened.A possible systematic error of the system can be excluded.The affected component was repaired on site by the local service organization.The error described in the complaint has not been reported again.In conclusion, it can be stated that the screws in question could not have been loosened automatically and that the system was not at fault.The evidence suggests that human error on the part of third parties was involved.

• Brand Name: ARTIS ZEE BIPLANE MN
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH- AT; siemensstrasse 1; forchheim, germany 91301 ; GM 91301
• MDR Report Key: 10527285
• Report Number: 3004977335-2020-45864
• Device Sequence Number: 3055473
• Product Code: OWB
• UDI-Device Identifier: 04056869010106
• UDI-Public: 04056869010106
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,foreig
• Initial Reporter Occupation: Other
• Remedial Action: Repair,Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2020

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: 10094143
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/09/2020
• Supplement Date Received by Manufacturer: 10/08/2020
• Initial Report FDA Received Date: 09/14/2020
• Supplement Report FDA Received Date: 10/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1