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

Model Number 10837643

Device Problem Use of Device Problem (1670)

Patient Problems Hearing Loss (1882); Patient Problem/Medical Problem (2688)

Event Date 01/15/2019

Event Type  Injury  

Manufacturer Narrative

Despite several requests for additional information, no information was provided to siemens regarding the reported incident.The manufacturer is not considering further actions resulting from this event as no systematic error has been recognized.

Event Description

It was reported to siemens that an adverse event occurred following examination on the magnetom spectra system.Two weeks after examination, a patient reported to be suffering from tinnitus.Approximately eight weeks after examination, the patient continues to experience tinnitus.Despite several requests for additional information, no information was provided to siemens regarding the reported incident.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.Assessment of the log files does not indicate a system failure or malfunction and no non-conformity was identified.A completed qa (quality assurance) report of the system before and after this case was reviewed and no abnormalities were detected.The system works as specified and no system noise was identified.No hardware or software problem was identified and the system works as specified.No further actions are to be taken as there is no negative awareness in regards to 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: 8526534
• MDR Text Key: 142328825
• Report Number: 3004754211-2019-76879
• 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: Inspection
• Type of Report: Initial,Followup
• Report Date: 04/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10837643
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other