CINEMAVISION

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-05-24 for CINEMAVISION manufactured by Resonance Technology, Inc.

Event Text Entries

[19843509] On (b)(6) 2008, our daughter was offered mri approved video goggles to watch a movie during user facility's mri. The goggles malfunctioned and projected a piece of tungsten metal fiber into her eyelid. The user facility's mri tech did not hear her cries for help as the pt microphone was turned down and the mri did not have a panic button. The fiber was confirmed to have come from the goggles by the user facility's bio med dept. Additionally, the event facility's mri tech provided a statement in (b)(6) 2011, that the goggles had, prior to this incident, been repaired by the user facility's bio med dept because the goggles plastic cover has fallen off. Our daughter's injuries required both emergency and f/u medical care to prevent permanent impairment and/or damage to eyelid and eye. Initial emergency care required an eye surgeon to remove the tungsten fiber that had soldered to her left eyelid and treatment of multiple eyelid lacerations. F/u care required repeated visits to assure no infection or add'l vision impact.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5025600
• MDR Report Key: 2597436
• Date Received: 2012-05-24
• Date of Report: 2012-05-24
• Date of Event: 2008-04-17
• Date Added to Maude: 2012-06-05
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: CINEMAVISION
• Generic Name: MRI VIDEO GOGGLES
• Product Code: HOY
• Date Received: 2012-05-24
• Operator: HEALTH PROFESSIONAL
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: RESONANCE TECHNOLOGY, INC
• Manufacturer Address: NORTHRIDGE CA US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2012-05-24