MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH ARTIS Q CEILING; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number 10848281

Device Problem Use of Device Problem (1670)

Patient Problems Injury (2348); Electric Shock (2554)

Event Date 10/03/2018

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.

Event Description

It was reported to siemens that an adverse event occurred while servicing the artis q ceiling system.During a maintenance activity, a siemens service engineer received an electrical shock from the right thumb to the left thumb resulting in muscle contraction.The engineer was evaluated in the emergency room and began physical therapy to relieve muscle and nerve tightness in the neck and back as per the doctors directives.There is no report of impact to the state of health of any patient or user involved.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.The root cause was determined to be a user error.The generator has appropriate warning signs and it is described in the update instructions to disconnect all live parts of the generator and all its connected components.Afterwards, the non-existing electricity has to be controlled via measurement.The update instruction has been updated to make it clearer that a circuit which is supplied via an uninterruptible power supply is still live and must be disconnected separately via fuse f5.The manufacturer is not considering further actions resulting from this event as the update instructions were immediately adapted accordingly.

• Brand Name: ARTIS Q CEILING
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forccheim, germany 91301 ; GM 91301
• MDR Report Key: 8482626
• MDR Text Key: 140906170
• Report Number: 3004977335-2018-51442
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• PMA/PMN Number: K123529
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10848281
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/27/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/03/2018
• Date Manufacturer Received: 02/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization