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

Model Number 10094139

Device Problem Use of Device Problem (1670)

Patient Problems Injury (2348); Superficial (First Degree) Burn (2685)

Event Date 01/25/2019

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.(b)(6).

Event Description

It was reported to siemens that an adverse event occurred while operating the artis zee multi-purpose system.During an electrocoagulation procedure, the nurse leaned her hand against the table resulting in reddening of the hand.We are unaware of any further impact to the state of health of the user involved.Siemens has requested additional information in order to conduct an investigation of the reported event.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.Assessment of the log files does not indicate a system failure or malfunction and no non-conformity was identified.The operator suffered an electric shock when she leaned against the siemens patient table with the foreign product (olympus esg-300 - electro-cutter) in her hand.The siemens technician went on site to check the system.Among other things, earth bond tests were carried out on the accessible parts.All parts are properly grounded and the system works as specified.No error has been detected on the siemens system at all.The most probable cause for the electric shock is a ground fault when the nurse touched the patient and conducting parts of the table simultaneously.With the activation of the electro-cutter (non-siemens product) the current ran through the nurses' arm to ground creating the burning sensation.The siemens system has been checked on site and is working according to the specification and no malfunction has been identified.The manufacturer is not considering further actions resulting from this event as no error has been recognized.

• Brand Name: ARTIS ZEE MULTI-PURPOSE
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forccheim, germany 91301 ; GM 91301
• MDR Report Key: 8452426
• MDR Text Key: 139869731
• Report Number: 3004977335-2019-70191
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• PMA/PMN Number: K141574
• 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: 01/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2019
• 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
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/31/2019
• Event Location: Hospital
• Date Report to Manufacturer: 01/31/2019
• Date Manufacturer Received: 05/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other