MAUDE Adverse Event Report: CARMA SALUD, S.L. QUADRATURE LOWER EXTREMITY COIL

Model Number 9896-031-02462

Device Problem Material Deformation (2976)

Patient Problem No Information (3190)

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.Coil part number is 9896-031-02462 and will be updated on the follow up report.

Event Description

The 1.5t hd t/r knee/foot coil was returned to invivo's service and repair with no indication from customer of escalation.While examining the product it was noticed that there was thermal deformation of the inner most portion (of the exterior housing) where a patients leg would be scanned.

Manufacturer Narrative

Upon arrival to invivo¿s service and repair department the coil¿s housing was visually damaged due to excessive heating and a smell of burnt plastic was noticed, initial information contained within the service record showed that this malfunction was potentially developed during clinical use of the mri coil.However after engineering evaluation it was concluded that this condition developed while the coil was not in clinical use and was left unplugged on the mri table, in principal this malfunction does not meet the event reporting criteria for malfunctions.In addition, the interior parts of the coil were visually inspected by development engineering and it was noticed that there were clear signs of over-voltage, over-current that resulted in the arcing dielectric breakdown and eventually leading to the failure of the product.Consistent with the product damage failure when this type mri coils are nor connected to the mri system for analysis.This device should not be present in the mr scanner while disconnected.When disconnected, the high power from the body coil will cause excessive power develop in the coil and cause the coil to burn up.All of this indicative from the fact that the match components are burnt and that the power resistor connected at the isolation port are burnt.A high power from the body will cause these high currents to develop when left unconnected in the magnet.With the cable being unplugged at the time of the event, the coil is not in clinical use therefore if the malfunction were to re-occur no injury is expected.

• Brand Name: QUADRATURE LOWER EXTREMITY COIL
• Type of Device: QUADRATURE LOWER EXTREMITY COIL
• Manufacturer (Section D): CARMA SALUD, S.L.; c/ discóbolo, 91-p4-2ºa; madrid 28022 ; SP 28022
• Manufacturer (Section G): PHILIPS HEALTHCARE - INVIVO DIAGNOSTIC IMAGING; 3545 sw 47th ave; gainesville FL 32608
• Manufacturer Contact: kenneth revennaugh ; c/ discóbolo, 91-p4-2ºa; madrid 28022 ; SP 28022
• MDR Report Key: 6849971
• MDR Text Key: 85272902
• Report Number: 1056069-2017-00003
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K934396
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 08/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9896-031-02462
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other