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

Model Number 10655588

Device Problem Excessive Heating (4030)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 12/09/2020

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 spectra system.While undergoing an examination with the body 12 coil, a female patient reported an area of redness on the left thigh.The patient was treated with silver sulfadiazine and the redness disappeared after a few days.We are unaware of any further impact to the state of health of the patient 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.The root cause could not be determined.Following this incident, the system was checked by the local service engineer.All system checks were completed successfully, and the system was found to be operating within specification.A save log when the incident occurred was not provided.Therefore, it was not possible to check whether any abnormal situation occurred during scanning.Review of the qa and tune-up reports show the system was operating within specification with the exception of the body 12 coil.The body 12 coil was not returned for investigation and it could not be confirmed if some coil elements were broken.Regarding the design of coils; several safety measures are taken, including passive /active detune, fuse cutout and sufficient thick cable sleeves to avoid serious injury.The dicom images of the examination were reviewed and it was noted that some image quality was not satisfactory.Based on the original description of the incident "in the image, this region is shown with low signal (darker)", the pointed location is exactly the location in which the patient felt a heating sensation.There is a local b1 distortion artifact which may be caused by a defective coil element; however, this cannot be confirmed as the coil was not returned for investigation.The service engineer exchanged the body 12 coil.After coil replacement, there were no further issues reported and the system works as intended.No further actions are to be taken as there is no negative awareness regarding the quality and performance of the system.

• Brand Name: MAGNETOM SPECTRA
• 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: 11038420
• MDR Text Key: 222365149
• Report Number: 3004754211-2020-59329
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• PMA/PMN Number: K153447
• 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: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10655588
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other