MAUDE Adverse Event Report: INVIVO CORPORATION QUADRATURE LOWER EXTREMITY COIL

Model Number 9896-031-02462

Device Problems Defective Device (2588); Connection Problem (2900); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Known Impact Or Consequence To Patient (2692)

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 coil was previously in use at turkish site: bilim ozel tip merkezi.The end user called the distributor (ge) to report that coil had "no connectivity".Ge found that a mcqa test failed and a cable replacement did not resolve the issue.Ge replaced the coil and sent the defective coil to invivo for service and repair.Upon arrival at invivo, the service and repair department identified warped housing on the qle coil.

Manufacturer Narrative

A ge 1.5t hd qle, 4535-300-77532, serial number: (b)(6), was returned to invivo service & repair for a coil fault.During the repair inspection process, a heating situation was observed.No other information was provided.The coils investigation was delayed as the coil was returned during the covid-19 pandemic and due to work restrictions the engineering team responsible did not have access to investigate in a timely manner.The coil was sent to repair and engineering evaluation in a condition where it cannot be tested further.Severe damage has rendered the assembly and the parts used in the coil to be non-functional (coil was submitted for engineering evaluation without system cable or pre-amp assembly attached to coil.) r1 on sub-board assembly has been exposed to overcurrent conditions upon visual inspection.The coil was severely damaged and no further tests can be performed on the coil.Also, the coil was submitted for evaluation missing the system cable as well as the pre-amp assembly.The 50 ohm resistor at location r1 on sub-board assembly has been exposed to overcurrent conditions upon visual inspection.This component has a power rating of 25 watts and a maximum voltage of 200 volts outlined in the component data sheet, see (b)(4).The 50 ohm resistor at location r1 is in place to absorb excessive reflected currents during the normal operation of the coil.These reflected currents do not exceed and go beyond the power rating of the resistor in normal use.However, when the coil is placed in the system and the body coil is turned on, current entering the device gets dissipated at this resistor.In previous experience this mode of failure occurs when a high rf power of several watts is incident 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 cannot 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 and the body coil was turned on.Therefore, 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.The returned coil was manufactured july 2017 and was returned march 2020 with no additional returns since it was manufactured.Based on the time that this coil was in the filed, there were 2700+ scans using this coil before the failure had occurred.This is based off of time in the field with an estimated 2.86 scans per day.From the information present, analysis performed, and from previous experience, the most probable cause of fault is operator error; the coil is 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.Please see section 5-2 in (b)(4).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
• Type of Device: QUADRATURE LOWER EXTREMITY COIL
• Manufacturer (Section D): INVIVO CORPORATION; 3545 sw 47th ave; gainesville FL 32608
• MDR Report Key: 9907676
• MDR Text Key: 202731731
• Report Number: 1056069-2020-00003
• Device Sequence Number: 1
• Product Code: LNH
• UDI-Device Identifier: 00884838067110
• UDI-Public: 00884838067110
• Combination Product (y/n): N
• PMA/PMN Number: K934396
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 03/10/2020

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
• Device Operator: 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: 03/05/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/09/2020
• Initial Date FDA Received: 03/31/2020
• Supplement Dates Manufacturer Received: 03/09/2020
• Supplement Dates FDA Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1