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

Model Number 10276755

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 05/30/2017

Event Type  Death  

Manufacturer Narrative

(b)(4).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.This event occurred in (b)(6).

Event Description

It was reported to siemens that an adverse event occurred while operating the magnetom verio system.A (b)(6) baby was anesthetized for a clinical procedure.Five minutes after anesthetization, the baby was introduced to the mr area to initiate the procedure.Two minutes after introduction to the mr area, it was reported the baby passed away.It is not known what type of procedure was to be performed.Additionally, the cause of the baby's death is unknown and under investigation.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.Assessment of the log files did not indicate a system failure or malfunction and no non-conformity was identified.A (b)(6) month old baby was anesthetized and five minutes later brought into the magnetic resonance area to initiate a procedure.Two minutes later the baby passed away.The customer provided information that the baby had convulsed in the days before the procedure and was sent to the diagnostic center for a study requested by his neurologist.Additionally, the customer indicated that the baby was in a delicate condition and the death was not caused by the mr system.Unfortunately, the customer did not provide any further information on the cause of the baby's death.The protocols of the preventive maintenance before the issue occurred have been checked.The system was also checked on (b)(6) 2017 following the patient death.Both checks showed that the system was operating within specification and optimum operating conditions.

• Brand Name: MAGNETOM VERIO
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH, MR QT; henkestrasse 127; erlangen, 91052 ; GM 91052
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; henkestrasse 127; erlangen, 91052 ; GM 91052
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 6104486461
• MDR Report Key: 6610451
• MDR Text Key: 76599282
• Report Number: 3002808157-2017-03089
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K072237
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 05/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10276755
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/31/2017
• Event Location: Hospital
• Date Report to Manufacturer: 05/31/2017
• Date Manufacturer Received: 02/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 7 MO