MAUDE Adverse Event Report: SUNNEX, LLC SUNNEX CSTAR; CS2050M-MRI

Model Number CS2050M-MRI

Device Problem No Apparent Adverse Event (3189)

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

Event Date 01/19/2021

Event Type  malfunction  

Manufacturer Narrative

Sunnex has been in contact with the user facility and is working with them.An investigation has begun and sunnex is anticipating receiving the light back for evaluation and inspection.No patient information was provided by the user facility.No one was injured due to this event.

Event Description

Mri light was attracted to the mri machine.

• Brand Name: SUNNEX CSTAR
• Type of Device: CS2050M-MRI
• Manufacturer (Section D): SUNNEX, LLC; 8001 tower point drive; charlotte NC 28227
• Manufacturer (Section G): SUNNEX, LLC; 8001 tower point drive; charlotte NC 28227
• Manufacturer Contact: bill long ; 8001 tower point drive; charlotte, NC 28227 ; 8004457869
• MDR Report Key: 11585790
• MDR Text Key: 243921828
• Report Number: 1226700-2021-00001
• Device Sequence Number: 1
• Product Code: KZF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K930711
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CS2050M-MRI
• Device Catalogue Number: CS2050M-MRI
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/25/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/11/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1