MAUDE Adverse Event Report: SIEMENS HEALTHCARE, BUSINESS AREA ADVANCED THERAPY ARTIS ZEE BIPLANE; SYSTEM, X-RAY, ANGIOGRAPHIC

Model Number 10094141

Device Problems Failure to Reset (1532); Inaccurate Synchronization (1609); Application Program Problem (2880)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/13/2016

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.(b)(6).

Event Description

It was reported to siemens that a malfunction occurred while operating the artis zee biplane system.During a patient procedure, the customer reported the database was not in sync and the ivs and ias-a/b had no connection.A system restart was attempted, however, it was unsuccessful and the procedure was aborted.We are unaware of any impact to the state of health of the patient involved.

Manufacturer Narrative

Files showed the ivs system suddenly reported a "not ready" status on the axcs network.No specific errors could have been identified, however, the recording of the log file stopping abruptly indicates a hardware failure.The investigation of the hardware suggests that program drive performance is unsatisfactory and the ivs system is susceptible to failure.No other hardware defects were identified with the ivs bb1 pc.After the program drive was replaced, the ivs system worked as intended.In the event of an ivs program drive failure, the data between the ivs and the ias will not synchronize, but the acquired pixel data will still be available on the ias.In this event, the ivs was not available, therefore the system switched to backup review mode.In this mode, fluoro and acquisition are possible, however, the data is not transferred to the ivs for storage in the local database.The defective ivs was replaced and the system works as specified.The measure taken is sufficient to solve the problem and to prevent the failure from recurring.

• Brand Name: ARTIS ZEE BIPLANE
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• Manufacturer (Section D): SIEMENS HEALTHCARE, BUSINESS AREA ADVANCED THERAPY; siemensstrasse 1; forcheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHINEERS, ADVANCED THERAPIES; siemensstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 6104486461
• MDR Report Key: 6225161
• MDR Text Key: 64342611
• Report Number: 2240869-2017-07050
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K073290
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 12/27/2016

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: No Information
• Device Model Number: 10094141
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/13/2016
• Initial Date FDA Received: 01/05/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1