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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVIVO CORPORATION 1.5T QUADRATURE LOWER EXTREMITY COIL

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INVIVO CORPORATION 1.5T QUADRATURE LOWER EXTREMITY COIL Back to Search Results
Model Number 9896-031-07421
Device Problems Break (1069); Material Puncture/Hole (1504)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The investigation is still ongoing for this event. When the investigation is complete a follow-up report will be sent to the fda.
 
Event Description
The customer reported that the knee/foot coil is damaged. The reporter further stated that the coil heating event created a hole in the plastic. The customer could not perform their mri exam and there was no patient involvement.
 
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Brand Name1.5T QUADRATURE LOWER EXTREMITY COIL
Type of Device1.5T QUADRATURE LOWER EXTREMITY COIL
Manufacturer (Section D)
INVIVO CORPORATION
3545 sw 47th ave
gainesville FL 32608
Manufacturer (Section G)
PHILIPS HEALTHCARE - INVIVO DIAGNOSTIC IMAGING
3545 sw 47th ave
gainesville FL 32608
Manufacturer Contact
kenneth revennaugh
3545 sw 47th ave
gainesville, FL 32608
MDR Report Key9570027
MDR Text Key198598836
Report Number1056069-2020-00001
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 distributor
Reporter Occupation
Remedial Action Replace
Type of Report Initial,Followup,Followup
Report Date 01/07/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9896-031-07421
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/20/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/10/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/10/2001
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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