MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH 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 05/04/2021

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 when setting up for 3d, the machine produced an error code and would not allow further movement to set up for the spin.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 a hardware error.The investigation was performed considering complaint description, cs reports, system history, and system log files.The log file analysis shows that the system detected a misadjustment of a potentiometer for the flat detector (fd) lift.The potentiometer responsible for providing information about system positions did not deliver correct values.The system automatically detected an error by means of comparing the first source of information (encoder or second potentiometer) with the second source of information (potentiometer).As a result, the system movement speed was reduced, followed by a relevant message ("reduced stand/table speed") and, in addition, only 2d acquisition was still available because the 3d acquisition was aborted, followed by the followed message "3d: aborted" displayed for the customer.The customer service engineer adjusted the potentiometer and the system recovered.After hardware adjustment there were no further issues, and the system works as intended.The occurrence rate of the identified cause has been checked and no error accumulation has been identified.The occurrence rate is below the defined threshold and no further corrective action is necessary.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; siemensstr. 1; forchheim, germany 91301 ; GM 91301
• MDR Report Key: 12057128
• MDR Text Key: 258039682
• Report Number: 3004977335-2021-84888
• 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: 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2021
• 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: 07/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1