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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVIVO CORPORATION QUADRATURE LOWER EXTREMITY COIL

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INVIVO CORPORATION QUADRATURE LOWER EXTREMITY COIL Back to Search Results
Model Number 9896-031-02462
Device Problem Break (1069)
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
Coil was delivered to invivo service and repair. Upon receipt, thermal damage was noted on chimney housing. Note: the end user has confirmed that there was no patient involvement with respect to this issue.
 
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Brand NameQUADRATURE LOWER EXTREMITY COIL
Type of DeviceQUADRATURE 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 Key9689805
MDR Text Key196249006
Report Number1056069-2020-00002
Device Sequence Number1
Product Code LNH
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K934396
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,other
Reporter Occupation
Remedial Action Replace
Type of Report Initial,Followup
Report Date 01/15/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9896-031-02462
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/03/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/13/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/16/2009
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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