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

Model Number 10352127

Device Problem Use of Device Problem (1670)

Patient Problems Burn(s) (1757); Patient Problem/Medical Problem (2688)

Event Date 02/17/2020

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

It was reported to siemens that an adverse event occurred following examination on the magnetom essenza system.A patient reported a burn on the back of the left leg after a knee scan which resulted in a blister approximately 2 centimeters in diameter.The patient applied ointment and no further medical treatment was needed.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 does not indicate a system failure or malfunction and no non-conformity was identified.The patient was treated for a second degree burn with ointment under the supervision of the doctor and no further medical treatment was required.Siemens healthineers shenzhen clinical experts reviewed the patient's dicom images and no non-conformity was identified on the images.Review of the tune-up and qa reports was completed after the incident and the system is operating within specification.No system malfunction and no defect of the knee coil used was detected.The root cause for the patient injury could not identified.No further actions are planned by the manufacturer as no system malfunction was identified.

• Brand Name: MAGNETOM ESSENZA
• 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, china 51805 7; CH 518057
• MDR Report Key: 9756143
• MDR Text Key: 192712204
• Report Number: 3004754211-2020-20005
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• PMA/PMN Number: K161795
• 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: 02/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10352127
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 30 YR
• Patient Weight: 106