MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH- MR MAGNETOM SOLA; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number 11291455

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/24/2020

Event Type  malfunction  

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 a malfunction occurred while operating the magnetom sola system.During a cardiac study, the user reported that the system hung up, and the study had to be repeated.It is not known if additional contrast was administered.At this time, we are unaware of any 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 attempted an investigation of the reported event.It was stated in the complaint, that the system crashed during a cardiac study with contrast agent.The only way to continue was restarting the whole system which made it necessary to reinject contrast.The data available in this potential complaint does not contain sufficient information to conduct an investigation.Siemens was made aware on november 4, 2020 that the system received a software update and the savelog that is essential for the investigation is not available.

• Brand Name: MAGNETOM SOLA
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH- MR; henkestrasse 127; erlangen, germany 91052 ; GM 91052
• MDR Report Key: 10717390
• MDR Text Key: 212463704
• Report Number: 3002808157-2020-49136
• Device Sequence Number: 1
• Product Code: LNH
• UDI-Device Identifier: 04056869164809
• UDI-Public: 04056869164809
• Combination Product (y/n): N
• PMA/PMN Number: K192496
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11291455
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1