MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH- AT CIOS SPIN; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number 10308194

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Electric Shock (2554)

Event Date 03/05/2020

Event Type  Injury  

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

During assembly work on the production line of the medical device cios spin, a siemens employee received an electric shock.There is no report of impact to the state of health of the employee involved.Additional information has been requested in order to conduct an investigation of the reported event.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.The root cause was determined to be a voltage error.An employee at the manufacturing site in kemnath suffered a slight electric shock.In-depth tests revealed that, under unfavorable circumstances, dc voltage of up to 67.6 v dc was measured at connector x10.This connector is located on the c-arm which can be connected to the trolley with a connecting cable in-between.It is designed precisely for the purpose of disconnecting the cable while it is powered on.Therefore, after removing the cable, there should not be any voltage at connector x10.The investigation showed that a very specific pcb modification was the root cause of this behavior.The newly modified circuit board d819 (material number: 10500960, revision 04) has been given a resistor (r1000) in order to specifically de-energize certain parts.A side effect was that an electrolytic capacitor (electrolytic capacitor) reduced the voltage at x10 very slowly.Siemens has completed an adaptation of the circuit board design d818 of the generator.This change has been implemented in production, however, corrective measure are in progress on an update for the field.Correction for this error will be initiated via update ax027/20/s and ax028/20/s and will be reported to the fda under 21 cfr 806.This corrective action will eliminate the root cause of the problem and prevent the possibility of reoccurrence.

• Brand Name: CIOS SPIN
• 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: 9889119
• MDR Text Key: 190961707
• Report Number: 3004977335-2020-23098
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• PMA/PMN Number: K181550
• 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: 03/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 10308194
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other