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U.S. Department of Health and Human Services

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

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SIEMENS HEALTHCARE GMBH- MR MAGNETOM PRISMA FIT SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING Back to Search Results
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.
 
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Brand NameMAGNETOM PRISMA FIT
Type of DeviceSYSTEM, 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 Key12433711
MDR Text Key273559445
Report Number3002808157-2021-93523
Device Sequence Number1
Product Code LNH
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K173592
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
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 Received09/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number10849583
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received11/12/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 09/07/2021 Patient Sequence Number: 1
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