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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVIVO CORPORATION INVIVO SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

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INVIVO CORPORATION INVIVO SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING Back to Search Results
Model Number 1.5T QUAD EXTREMITY COIL T/R
Device Problem Temperature Problem (3022)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Event Description
"coil issue, forgot to plug coil while scanning foot resulting in coil damage. Foot/ankle shows a burn pattern mark on coil. Spoke to fe advised to run a phantom. Phantom shows signal loss at area in question. No patient contact according to the technologist.
 
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Brand NameINVIVO
Type of DeviceSYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
Manufacturer (Section D)
INVIVO CORPORATION
3545 sw 47th ave
gainesville FL 32608
Manufacturer (Section G)
INVIVO CORPORATION
3545 sw 47th ave
gainesville FL 32608
Manufacturer Contact
tom trace
3545 sw 47th ave
gainesville, FL 32608
MDR Report Key11273239
MDR Text Key231318175
Report Number1056069-2021-00001
Device Sequence Number1
Product Code LNH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K934396
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1.5T QUAD EXTREMITY COIL T/R
Device Catalogue Number453530264501
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/09/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Distributor Facility Aware Date01/08/2021
Event Location No Information
Date Manufacturer Received01/08/2021
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 Reuse

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