MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH ARTIS ZEE BIPLANE; SYSTEM, X-RAY, ANGIOGRAPHIC

Model Number 10094141

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/21/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.(b)(6).

Event Description

It was reported to siemens that a malfunction occurred while operating the artis zee biplane system.Incorrect vessel measurements were reported following a clinical procedure.A distance measurement mismatch occurs in the images sent from the artis zee biplane system to the ge(general electric ) pacs (picture archiving and communication system ) and measured at the workstation (ge-centricity).There is no report of impact to the state of health of any patient involved.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.The investigation showed that the system works as specified.No error of the system has been recognized, however, the root cause can be attributed to incorrect behavior of a foreign product.According to the dicom standard which is used in this network the dicom tags provide information for imager pixel spacing (pixel size on receptor plane) and estimated magnification (due to projection).In the example received from the site; the magnification factor is set to ~ 1.5; a measurement of 16 mm instead of 11 mm indicates that the none siemens pacs ignores the magnification factor.The distance measured on receptor plane needs to be divided by the magnification factor due to projection.Dicom clearly states that imager pixel spacing (0018,1164) "shall never be adjusted to account for correction for the effect of geometric magnification".Using the value without considering the magnification is an error on the none siemens pacs workstation.The manufacturer is not considering further actions at this time.

• Brand Name: ARTIS ZEE BIPLANE
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstrasse 1; forchheim, 91301 ; GM 91301
• MDR Report Key: 6861700
• MDR Text Key: 85992281
• Report Number: 3004977335-2017-92821
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• PMA/PMN Number: K073290
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 08/21/2017

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: 10094141
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/21/2017
• Event Location: Hospital
• Date Report to Manufacturer: 08/21/2017
• Initial Date Manufacturer Received: 08/21/2017
• Initial Date FDA Received: 09/13/2017
• Supplement Dates Manufacturer Received: 02/16/2018
• Supplement Dates FDA Received: 02/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1