MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH- AT ARTIS ZEE MULTI-PURPOSE; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number 10094139

Device Problem Use of Device Problem (1670)

Patient Problems Bruise/Contusion (1754); Patient Problem/Medical Problem (2688)

Event Date 05/15/2020

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.

Event Description

It was reported to siemens that an adverse event occurred while operating the artis zee multi-purpose system.During a procedure, it was reported that the patient jammed their arm between the table and the accessory rail resulting in a bruise to the upper arm.Siemens has requested additional information in order to conduct an investigation of the reported event.

Manufacturer Narrative

Siemens completed the investigation of the reported event.The investigation showed that the incident described in the complaint was not due to a system error.As the photos provided indicated, the circumstance described in the complaint event can only occur if work is carried out contrary to the operating instructions and the accessory rail is not moved accordingly before the patient is repositioned/transported, thus eliminating the danger zone of the accessory rail, including accessories during transport as described, in the complaint event.It is the responsibility of the operator to ensure that the access route to and from the system is free of obstacles.This is explicitly pointed out in the operating instructions.Nevertheless, the system has been inspected by our regional service department and found to be free from defects.The system works as specified.No system faults were found during on-site use.The system will continue to operate in the same condition.No further action is warranted at this time.

• Brand Name: ARTIS ZEE MULTI-PURPOSE
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH- AT; siemensstrasse 1; forchheim, germany 91301 ; GM 91301
• MDR Report Key: 10118181
• MDR Text Key: 193956042
• Report Number: 3004977335-2020-30549
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• PMA/PMN Number: K181407
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10094139
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other