MAUDE Adverse Event Report: SUNNEX, INC. SUNNEX; SUNNEX MEDICAL LIGHT

Model Number PF28016

Device Problems Component Falling (1105); Improper or Incorrect Procedure or Method (2017)

Patient Problem Bone Fracture(s) (1870)

Event Date 02/09/2017

Event Type  Injury  

Event Description

Unsecured mri conditional device, sunnex medical light battery pack - transformer was brought beyond its recommended gauss line for safe use, and was subsequently pulled out of an employee's hands.The employee attempted to catch the device and prevent it from entering the mri scanner, but was unsuccessful and subsequently fractured her fifth digit.The devices recommended use and mri conditions for use were identified and remedial action was performed.This included the permanent fixation of the transformer to the wall well outside the 5 gauss line.Education of the mri team, as to the conditions for use for all of their equipment that is used in their department, and also that have the potential to enter the mri zone 4.Then we had the physicist identify the 200 gauss and 5 gauss lines.As all of the equipment used do not exceed the 200 gauss value.Sunnex medical light - the actual light assembly itself is safe up to 5000 gauss, but the battery / transformer case is only safe to 100g.Just a recommendation but the mfr should require this box to be permanently fixed outside the 5 gauss lines, so as to eliminate any issues with facilities that bring the unit in and out of the mri scanner room, as a whole unit base/light and transformer.

• Brand Name: SUNNEX
• Type of Device: SUNNEX MEDICAL LIGHT
• Manufacturer (Section D): SUNNEX, INC.; 8001 tower point dr.; charlotte NC 28227
• MDR Report Key: 6335745
• MDR Text Key: 67695217
• Report Number: MW5067912
• Device Sequence Number: 1
• Product Code: KZF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PF28016
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention