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

Model Number 10094135

Device Problem No Apparent Adverse Event (3189)

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

Event Date 09/02/2021

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 zee floor system.During an interventional procedure, the user reported that every second image was damaged due to image artifacts.The procedure was continued and completed on an alternate system.We are unaware of any impact to the state of health of the patient 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.Unfortunately, the detailed examination could not provide a clear result.Although remedial action was taken on site, the copra/ceb board that was replaced and examined at the factory showed no fault and works as specified.Examination of the log files failed to provide a clear indication of the cause of the error.According to system specialists, it is conceivable that the digital image pre-processing (dipp) had a temporary malfunction.Most likely, the copra/ceb board was affected by this malfunction.Whether this was due to a contact or temperature problem could only be assumed, but not verified in retrospect.Since the situation at the customer's site has been rectified in the meantime by replacing the above-mentioned board, it is no longer possible to carry out a further investigation on site.The malfunction described above led to every second image having stripes on site, but this was completely eliminated after service intervention.Therefore, the system experts assume a temporary hardware defect of the copra/ceb board.According to the error pattern, probably in a memory bank of the two ram modules.This would at least explain the stripes in the images, because with such an error, only every second image on the monitor would be affected, which again coincides with the error description of the incoming notification.The system was repaired by replacing the copra/ceb board and it is working again as specified.The error mentioned in the complaint has not again been reported again.The occurrence rate of the mentioned error pattern and the spare parts consumption of the affected part were checked.A possible error accumulation or even a systematic error, which 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 ZEE FLOOR
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH- AT; siemensstrasse 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 ; 6104486461
• MDR Report Key: 12432523
• MDR Text Key: 272168695
• Report Number: 3004977335-2021-95612
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 04056869010045
• UDI-Public: 04056869010045
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K181407
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 09/07/2021

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: 10094135
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/02/2021
• Initial Date FDA Received: 09/07/2021
• Supplement Dates Manufacturer Received: 11/08/2021
• Supplement Dates FDA Received: 11/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1