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.During a clinical procedure, the user reported the table performed unrequested movements when the flat detector was in the front position.As a result, the patient was safely removed from the system and transferred to an alternate system where the procedure was completed.We are unaware of any impact to 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 reference switch for the table tilt was misaligned and falsely activated resulting in the described longitudinal movement.Following readjustment of the reference switch, the system recovered to normal operation.The manufacturer is not considering further actions resulting from this 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: 6844725
• MDR Text Key: 84995560
• Report Number: 3004977335-2017-92940
• 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: 08/22/2017

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/06/2017
• Event Location: Hospital
• Date Report to Manufacturer: 08/22/2017
• Initial Date Manufacturer Received: 08/22/2017
• Initial Date FDA Received: 09/06/2017
• Supplement Dates Manufacturer Received: 12/06/2017
• Supplement Dates FDA Received: 12/06/2017
• 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