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

Model Number 10094141

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 07/26/2017

Event Type  Death  

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.

Event Description

It was reported to siemens that a malfunction occurred while operating the artis zee biplane system.During a clinical procedure, the system froze.A system restart was attempted, however, it was unsuccessful.The patient was safely removed from the system and it was subsequently reported that the patient passed away.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.The problem was identified as a corrupted database due to a software error.The investigation of the log files showed that during system boot up the system control unit was registered and started subscribing but the remote event distributor server started delayed.Therefore the image visualization system (ivs) failed to boot properly.The ivs rebooted to recover from the issue but failed to completely startup.As a result, the system switched to backup review mode.In this mode fluoroscopic imaging and image acquisition are possible but the data cannot be transferred to the ivs for storage in the local database.A rebuild of the database was performed on the affected system and the reported system behavior did not recur.The manufacturer is not considering further actions resulting from this individual event.

• Brand Name: ARTIS ZEE BIPLANE
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forcheim, 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 6104486461
• MDR Report Key: 6776904
• MDR Text Key: 82143286
• Report Number: 3004977335-2017-89644
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073290
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 08/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10094141
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/08/2017
• Event Location: Hospital
• Date Report to Manufacturer: 08/08/2017
• Initial Date Manufacturer Received: 08/08/2017
• Initial Date FDA Received: 08/09/2017
• Supplement Dates Manufacturer Received: 01/16/2018
• Supplement Dates FDA Received: 01/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death