MAUDE Adverse Event Report: SIEMENS SHENZHEN MAGNETIC RESONANCE LTD. MAGNETOM SEMPRA; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number 10840815

Device Problems Electrical /Electronic Property Problem (1198); Unintended Electrical Shock (4018)

Patient Problem Electric Shock (2554)

Event Date 07/12/2021

Event Type  malfunction  

Manufacturer Narrative

Siemens is conducting a thorough investigation of the reported event.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 that two (2) employees at the customer site experienced an electrical shock sensation during the connection of the head coil to the patient table connectors, prior to performing the procedure.To date, there is no report of injury.This reported issue occurred in (b)(6).

Manufacturer Narrative

Siemens has completed an investigation of the reported event.Assessment does not indicate a system failure or malfunction and no non-conformity was identified.The detailed investigation showed that all coil qa tests were passed.Therefore, the function of these two coils was normal.It was found that only the cable sheath of the extremity coil was broken, but the cable insulating coating was functional and this would not cause electrical shock.No visual damage was found on the head coil.The highest voltage of head coil before scanning is 30v, which is under the human protection voltage 36v.All components used in mr comply with the iec60601-1 standards and the system grounding is well connected so an electrical shock is not possible.Based on the analyzation above and that the electrical shock sensation was very short but not strong, it is suspected that the reported electrical shock was the result of static discharge.Siemens monitored the system for two months and no similar electronic sensation issue were reported.The siemens service organization replaced the cable of the extremity coil.The head coil was not replaced, however, the system is working as specified.

• Brand Name: MAGNETOM SEMPRA
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS SHENZHEN MAGNETIC RESONANCE LTD.; gaoxin c ave.; 2nd, hi-tech industrial park; shenzhen, 51805 7; CH 518057
• MDR Report Key: 12231309
• MDR Text Key: 265445371
• Report Number: 3004754211-2021-88950
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• PMA/PMN Number: K163211
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 07/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10840815
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1