MAUDE Adverse Event Report: INVIVO CORPORATION QUADRATURE LOWER EXTREMITY COIL

Model Number	9896-031-02462
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional Manufacturer Narrative
A ge 1.5t hd qle, 4535-300-77532, serial number: (b)(6), was returned to invivo after a heating event for evaluation.No patient heating complaints were reported.During inspection it was noted that a hole was present in the housing of the coil at the point where a patient would usually be located during a scan.The ge coil was returned to invivo for repair.During the repair inspection process, a heating situation was observed.No other information was provided.The coil was sent to engineering for evaluation.The coil was in a condition where it could not be tested further.Severe damage has rendered the assembly and the parts in the coil to be non-functional.The results of the analysis and the causes of such an incident are as follows: the external housing appeared warped.This warp is caused due to high heat.A hole was noted in the chimney of the coil and the edges of the coil were discolored from heat.The coil was opened and inspected right underneath the hole.Heat had burnt through the fire shield.Visual inspection of the pcb shows evidence of an over-current situation that eventually led to arc and thermal breakdown.Capacitor c15 burnt and fell off the pcb board.The coil was severely damaged and further testing could not be performed on the coil.The preamp of the birdcage coil was still able to be tested.The performance of the preamp was reviewed.The input impedance of the preamp (s11) was outside specification.It was also observed that the preamp did not have any gain (s21).The gain should ideally be 26 db.However, in this case, the gain was -34.355 db.This concludes that the preamp has been damaged.This mode of failure occurs when a high rf power of several watts is on the input of preamplifier circuit.This kind of high rf power is possible when the rf body coil of the mri system is used as a transmitter.This design is not intended to be used with the mr body coil in transmit mode.From the evidence, and information presented, the most probable cause of failure is the placement of the coil unconnected inside in the mri system.The mri system was turned on and the body coil was turned on.The body coil is not designed to be turned on when the coil is connected to the system.The body coil of the mri system can generate a power of greater than 10kw.This fact points to the conclusion that the coil was left in the mri system while the body coil was turned on.The cause of this defect and damage is leaving an unconnected tr coil inside the mri system while running the body coil in the transmit mode.From the information present, analysis performed, and from previous experience the most probable cause of fault is operator error; the coil was left unconnected inside the mri system and body coil was used to transmit power into the coil.This coil has been used against the instructions in the ifu and the user did not pay attention to the ifu of the coil.The device was originally manufactured according to its specification which included all designed safety features and is considered a safe and usable device, when used according to its intended use/indications for use.The product's risk file describes all hazards and risk controls accordingly.A review of the risk file indicates that normal operation will not cause parts to overheat.Components may locally warm up, but are enclosed in a rigid housing.Abnormally high power operation could cause parts to warm up to the point that the housing around the components gets too warm for patient contact.Leaving the coil unconnected is an operator error against the instructions in the ifu and product caution label.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: QUADRATURE LOWER EXTREMITY COIL
• Common Device Name: QUADRATURE LOWER EXTREMITY COIL
• Manufacturer (Section D): INVIVO CORPORATION; 3545 sw 47th ave; gainesville FL 32608
• MDR Report Key: 9689805
• Report Number: 1056069-2020-00002
• Device Sequence Number: 3002395
• Product Code: LNH
• UDI-Device Identifier: 00884838067110
• UDI-Public: 00884838067110
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K934396
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 9896-031-02462
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/13/2020
• Supplement Date Received by Manufacturer: 01/13/2020
• Initial Report FDA Received Date: 02/10/2020
• Supplement Report FDA Received Date: 03/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1