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

Model Number 10094141

Device Problem Loss of Data (2903)

Patient Problem Cardiac Arrest (1762)

Event Date 07/02/2016

Event Type  Injury  

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 patient suffered a cardiac arrest during a procedure on the artis zee biplane system.During the procedure the customer was deleting patient data, however, the recycle bin was occupied and the database was not in sync.An on/off power cycle was attempted, but not successful resulting in an abort of the scan and report of the patient experiencing cardiac arrest.We are unaware of the state of health of the patient involved.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.During the investigation it was determined that the default settings for "auto transfer" and "auto delete" were no longer available after maintenance and an update were performed by the manufacturer's service organization.Once the memory is running full, no further acquisition can be recorded, however, fluoroscopy is possible without limitation.The operator receives a failure message "memory full, delete patients" and is able to gain memory by disposal of data for further recording of single images and scenes.The error message "memory full, delete patients" first appeared after 18 minutes and recognition of this message lead to a delay of the procedure.The root cause was determined as a workmanship error of the engineer as well as suboptimal error handling of the system software.Default settings were reset and the problem did not recur.Reoccurrence of this combination of a workmanship error and a suboptimal error handling is rated remote, however, a more precise description of the service documentation and an improved handling of "full disc errors" will be considered.

• Brand Name: ARTIS ZEE BIPLANE
• Type of Device: SYSTEM, XRAY, ANGIOGRAPHIC
• Manufacturer (Section D): SIEMENS HEALTHCARE, BUSINESS AREA ADVANCED THERAPY; siemensstrasse 1; forcheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE, BUSINESS AREA ADVANCED THERAPY; siemensstrasse 1; forcheim, 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd; 65-1a; malvern, PA 19355 ; 6104486461
• MDR Report Key: 5785334
• MDR Text Key: 49278822
• Report Number: 2240869-2016-03885
• 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,user f
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 07/04/2016

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: No Information
• Device Model Number: 10094141
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/04/2016
• Initial Date FDA Received: 07/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/09/2016
• 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
• Patient Outcome(s): Hospitalization