MAUDE Adverse Event Report: SUNNEX, LLC SUNNEX MRI CELESTIAL STAR MOBILE SURGICAL LIGHT; DEVICE MEDICAL EXAMINATION, AC POWERED

Model Number CS2050M

Device Problem Device-Device Incompatibility (2919)

Patient Problem Injury (2348)

Event Date 05/26/2018

Event Type  No Answer Provided  

Event Description

A power supply unit for a rolling surgical light was wheeled into zone 4 on a cart which was brought in too close to the magnet.The power supply unit was attracted to the bore of the 1.5t siemens aera, causing minor injury to a surgical technologist.The mri technologist had just completed the weekly acr phantom test and began to wheel out the mr exam table when the dbs team began to introduce the procedure equipment ito zone 4 (mr exam room).

• Brand Name: SUNNEX MRI CELESTIAL STAR MOBILE SURGICAL LIGHT
• Type of Device: DEVICE MEDICAL EXAMINATION, AC POWERED
• Manufacturer (Section D): SUNNEX, LLC; charlotte NC
• MDR Report Key: 7596154
• MDR Text Key: 111090280
• Report Number: MW5077806
• Device Sequence Number: 1
• Product Code: KZF
• Combination Product (y/n): N
• 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: 06/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CS2050M
• Device Catalogue Number: CS2050M
• 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 Age: 66 YR