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

Model Number 10848282

Device Problems Display or Visual Feedback Problem (1184); Poor Quality Image (1408); Output Problem (3005)

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

Event Date 08/24/2021

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.Internal id #: (b)(6).

Event Description

It was reported to siemens that a malfunction occurred while operating the artis q biplane system.Images became distorted during an iliac angioplasty procedure.According to the user, the images had some grid/raster pattern over them.There is no report of impact to the state of health of any patient or user involved.The procedure was successfully completed on an alternate machine.Siemens has requested additional information in order to conduct an investigation of the reported event.The described event occurred in (b)(6).

Manufacturer Narrative

Siemens has completed an investigation of the reported event.The root cause was determined to be a hardware error.During an interventional procedure the x-ray images became distorted (showed grid/raster pattern over it) on plane a of a biplane system.Plane b was not affected.The interventional procedure was continued and finished using an alternative system.Such a pattern of artifact could be caused by defective circuit boards.To resolve the issue the "copra/ceb" board was replaced as part of service activity.The problem did not occur again afterwards.The replaced "copra/ceb" board was examined at the factory but did not reveal any error.Examination of the log files also failed to provide a clear indication of the cause of the error.Therefore, the system experts assume a temporary hardware defect of the "copra/ceb" board, according to the error pattern probably in one memory bank of the ram modules.A possible error accumulation or even a systematic error that would lead 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 BIPLANE
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• MDR Report Key: 12385975
• MDR Text Key: 268783124
• Report Number: 3004977335-2021-94427
• 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,foreig
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 08/30/2021

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
• Device Operator: Health Professional
• Device Model Number: 10848282
• Initial Date Manufacturer Received: 08/24/2021
• Initial Date FDA Received: 08/30/2021
• Supplement Dates Manufacturer Received: 10/26/2021
• Supplement Dates FDA Received: 10/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other