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 Problems Bruise/Contusion (1754); Injury (2348)

Event Date 01/01/2017

Event Type  Injury  

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.This event occurred in (b)(6).

Event Description

It was reported to siemens that an adverse event occurred while operating the axiom artis zee biplane system.The lower body radiation protection fell onto the users foot resulting in a bruise to the top of the foot.We are unaware of any medical treatment needed or any impact to the state of health of any patient or user involved.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.The investigation showed that the error described in the complaint could only happen if the clamp which holds the lower body radiation protection was not tightened thoroughly by the user.In the operator manual of the lower body radiation protection it is well described how to do this.The system works as specified and 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; siemenstrasse 1; forcheim, 91301 ; GM 91301
• MDR Report Key: 6893633
• MDR Text Key: 87352462
• Report Number: 3004977335-2017-96219
• 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: 09/11/2017

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
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/11/2017
• Event Location: Hospital
• Date Report to Manufacturer: 09/11/2017
• Initial Date Manufacturer Received: 09/11/2017
• Initial Date FDA Received: 09/26/2017
• Supplement Dates Manufacturer Received: 01/16/2018
• Supplement Dates FDA Received: 01/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other