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

Model Number 10848282

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/03/2021

Event Type  malfunction  

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 Description

It was reported to siemens that a malfunction occurred while operating the artis q biplane system.The user reported that the head holder broke along the welds.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.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.The root cause was determined to be misuse/ user error.The investigation was performed considering complaint description, cs reports, system history, and system log files.In the opinion of the technical expert, the most feasible root cause for the head holder to be broken along the welds is an external force such as a collision, dropping the head holder to the floor, or very high forces from undefined directions (e.G.From the side) towards the head holder.According to the manufacturer the load of the allowed 10kg cannot lead to a defective head holder as there were support loading tests performed according iec 60601-1:2012, cl.9.8.The tests passed and afterwards the load was increased until a breaking of the head holder was detected.The head holder broke at a total load of 84,6kg which indicates the loading factor (8x) was much higher than required (4x).A systematic failure in the welding is very unlikely as there are no other failures known of this kind.It is stated in the user manual under danger zones/ danger points: to avoid collisions, the display ceiling suspension, radiation protection devices and other accessories should be outside the c-arm system.After exchange of the head holder the system works as intended.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 BIPLANE
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH- AT; siemensstrasse 1; forchheim, germany 91301 ; GM 91301
• MDR Report Key: 11342153
• MDR Text Key: 234330114
• Report Number: 3004977335-2021-67115
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 04056869009995
• UDI-Public: 04056869009995
• Combination Product (y/n): N
• PMA/PMN Number: K181407
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10848282
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1