MAUDE Adverse Event Report: INVIVO CORP SENSE HEAD COIL 1.5T 8 CH; NONE

Model Number 4522-132-14165

Device Problem Insufficient Information (3190)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 06/06/2014

Event Type  Injury  

Event Description

Philips received a report of a heating incident.A patient was scanned on an achieva mr system with the sense head coil.Blistering (2nd degree) was noted after the examination at the upper rear triceps area of the patient's left arm.The total size of the blisters is reported to be covering one and a half square inch.

Manufacturer Narrative

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

• Brand Name: SENSE HEAD COIL 1.5T 8 CH
• Type of Device: NONE
• Manufacturer (Section D): INVIVO CORP; 3545 s.w. 47th ave.; gainesville FL 32608
• Manufacturer Contact: kenneth revennaugh, director ; 3545 s.w. 47th ave.; gainesville, FL 32608 ; 3523360010
• MDR Report Key: 3970972
• MDR Text Key: 4628203
• Report Number: 1056069-2014-00002
• Device Sequence Number: 1
• Product Code: MOS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 4522-132-14165
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/20/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 86