MAUDE Adverse Event Report: SUNNEX LLC SUNNEX CELESTIAL STAR / PROCEDURE LIGHT; DEVICE, MEDICAL EXAMINATION, AC POWERED

Model Number CS2050M

Device Problems Break (1069); Electromagnetic Interference (1194)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/19/2021

Event Type  malfunction  

Event Description

The patient's body was inside the bore of the mri machine with his head located on the backside of the mr unit.The neurosurgeon was using the mobile mri biopsy light to plan trajectory.The static magnetic field attracted the light and it was pulled to the mr unit and lodged against the bore of the magnet.The outside panels of the mri machine broke upon impact.The patient was immediately removed from the room.Neither the patient nor the surgeon were injured.Fda safety report id# (b)(4).

• Brand Name: SUNNEX CELESTIAL STAR / PROCEDURE LIGHT
• Type of Device: DEVICE, MEDICAL EXAMINATION, AC POWERED
• Manufacturer (Section D): SUNNEX LLC
• MDR Report Key: 11342486
• MDR Text Key: 232822727
• Report Number: MW5099438
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 02/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CS2050M
• Device Catalogue Number: CS2050M
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• 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): Other
• Patient Age: 54 YR