MAUDE Adverse Event Report: INVIVO/PHILIPS INVIVO/PHILIPS; SENSE KNEE COIL 1.5T 8CH

Model Number 9896-030-11603

Device Problem Insufficient Information (3190)

Patient Problems Swelling (2091); Partial thickness (Second Degree) Burn (2694)

Event Date 08/07/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).The investigation is still ongoing on this event.When the investigation is completed a follow-up report will be sent to the fda.

Event Description

Invivo/philips received a report from a customer that a blister formed on the upper left thigh of a patient after an mr examination.The patient was positioned feet first for an examination of the right knee using the 8ch knee coil.Injury was classified as 2nd degree burn greater than 2.5cm.

Manufacturer Narrative

(b)(4).Based on the provided information and test performed on site and at the repair facility, it is concluded that the reddening of skin and blisters on the left leg were caused by contact between the coil cable and the patients leg.The padding that was placed between leg and cable shifted during the examination.As contributing factors were identified: a broken tuning capacitor of the coil used, that may have led to high cable currents in certain situations - the use of consecutive high sar scans (> 2wkg) - the routing of the cable (not parallel to the bore, but across).The instructions for use contains extensive warnings related to patient and coil/ cable positioning.It is clearly mentioned that 2 cm distance must be kept between coil cable and patient.

• Brand Name: INVIVO/PHILIPS
• Type of Device: SENSE KNEE COIL 1.5T 8CH
• Manufacturer (Section D): INVIVO/PHILIPS; 3545 sw 47th avenue; gainesville FL 32608
• Manufacturer Contact: kenneth revennaugh ; 3545 sw 47th avenue; gainesville, FL 32608 ; 3523360010
• MDR Report Key: 5055767
• MDR Text Key: 24991466
• Report Number: 1056069-2015-00006
• Device Sequence Number: 1
• Product Code: MOS
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K033567
• 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: Followup
• Report Date: 08/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9896-030-11603
• Device Catalogue Number: 9896-030-11603
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2010
• 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
• Patient Age: 33 YR