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

Model Number 10849583

Device Problem Device Unsafe to Use in Environment (2918)

Patient Problems Fatigue (1849); Discomfort (2330)

Event Date 08/11/2021

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 while performing maintenance on the magnetom prisma fit system.It was stated that the magnet quenched unexpectedly while three customer service engineers (cse) prepared for ramping down of the magnet.When the magnet quenched, all cses exited the examination room immediately and closed the door behind them.The cses continued working.In the afternoon, when two of the cses refilled the magnet with liquid helium, the two cses started to notice a deterioration of their health.They complained about joint pains, sweating and digestion problems.Because their health problems persisted, the cses went to a hospital the next day to be medically checked.It was found that their oxygen saturation was very low.Therefore, the cses were put on oxygen for 6 hours and were put on sick leave.The two cses continued to undergo various exams, however, the severity of their injuries could not yet be determined with absolute certainty.The two cses continue to be under medical supervision and are currently still on sick leave.We therefore perform an in-doubt reporting.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.The root cause was determined to be a workmanship error.It was stated that the magnet quenched while three customer service engineers (cse) prepared for ramping down of the magnet.Later, when two of the cses refilled the magnet with liquid helium, the two cses started to notice a deterioration of their health.They complained about joint pains, sweating and digestion problems.Because their health problems persisted, the cses went to a hospital the next day to be medically checked.It was found that their oxygen saturation was very low.Therefore, the cses were put on oxygen for 6 hours and were put on sick leave.Both were under medical supervision.After this incident the system was checked and found to be operating within specification.Therefore, it does not reasonably suggest that the incident is related to a malfunction of the device.The unfortunate quench event is most likely related to the service activity.Three customer service engineers (cses) were on site to change the gradient coil of the magnet.Therefore, it was necessary to ramp down the superconducting magnet.For this, a probe must be inverted into an opening of 4cm in diameter.The magnet was still open due to the probe when the magnet quenched.Through this opening evaporating helium flowed into the room.Due to possible hazards in this working step, special safety measures must be adhered to in order to prevent injuries.The instructions for use or 64 for prisma fit magnets (doc.No.M7-040.815.20.08.02.05.20) provide clear instructions and warnings regarding ramping the magnet with regards to safety: caution, if the magnet quenches while inserting or removing the ecl, oxygen in the room will be displaced by helium - risk of suffocation or cold burns.If not observed, cold burns and suffocation may occur.Immediately leave the rf cabin and, as far as possible, close the door and secure the environment, until the gas flow from the magnet subsides.· before entering the rf cabin again, check the oxygen level with an oxygen monitor.These instructions and the compliance with the warnings and safety instructions are obligatory for every user.Furthermore, all cses are trained annually and made aware of possible hazards.Upon occurrence of the quench all cses exited the examination room immediately and closed the door behind them.At that time all three cses felt well and continued working.After a while two of the three cses went back to the mr room and did some after quench tasks to avoid the magnet getting warm.One of them took a lhe detection tool (oximeter) with him to check the oxygen level in the room.The oximeter showed an oxygen level of around 21%, which is in the green zone.During filling of the magnet with liquid helium, the magnet is open again and it is possible that helium leaks out.Therefore, there is also a warning in the instructions for use (or 64 for prisma fit magnets; doc.No.M7-040.815.20.08.02.05.20).Warning: risk of asphyxiation.Failure to observe the following safety warning may result in dizziness and loss of consciousness in personnel working with cryogen.Oxygen monitors must be activated at all times.Do not vent helium gas continuously into the magnet room during helium transfer.Check room ventilation if turned on.If the instructions for use are followed, there is no risk to health.In addition, post market surveillance shows that this is the first event where health problems in this form have been reported during refilling a magnet.

• Brand Name: MAGNETOM PRISMA FIT
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH- MR; henkestrasse 127; erlangen, germany 91052 ; GM 91052
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH - MR; henkestrasse 127; erlangen, germany 91052 ; GM 91052
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; malvern, PA 19355 ; 6104486461
• MDR Report Key: 12433711
• MDR Text Key: 273559445
• Report Number: 3002808157-2021-93523
• Device Sequence Number: 1
• Product Code: LNH
• UDI-Device Identifier: 04056869006734
• UDI-Public: 04056869006734
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K173592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 09/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 10849583
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other