MAUDE Adverse Event Report: SUN NUCLEAR CORP. IC PROFILER-MR

Model Number 1123

Device Problems Unintended Collision (1429); Device Operates Differently Than Expected (2913); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/06/2014

Event Type  malfunction  

Event Description

Staff using an ic profiler-mr at (b)(6) radiation oncology reported their ic profiler-mr unit that was resting on the couch moved when the couch was translated into a magnetic field of a viewray delivery system.No injury was reported.

Manufacturer Narrative

The ic profiler-mr is not used in the presence of a patient.However, staff setting up the ic profiler-mr for measurement of an installed viewray delivery system could experience a pinch hazard between the covers on the delivery system and the ic profiler-mr if it is attracted towards the delivery system by the magnetic field.Investigation identified an assembly error of this unit.There were 3 units manufactured in the lot and 9 units manufactured in total.As part of the investigation of this incident, all units manufactured have been evaluated.Data obtained confirmed 2 units contained the assembly error.These units have been removed and repaired.

• Brand Name: IC PROFILER-MR
• Type of Device: IC PROFILER-MR
• Manufacturer (Section D): SUN NUCLEAR CORP.; melbourne FL
• Manufacturer Contact: jonathan lee ; 3275 suntree blvd; melbourne, FL 32940 ; 3212596862
• MDR Report Key: 4084960
• MDR Text Key: 16310032
• Report Number: 1038814-2014-00001
• Device Sequence Number: 1
• Product Code: LHO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 08/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1123
• Device Lot Number: W92327
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/08/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/06/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: VIEWRAY SYSTEM
• Patient Outcome(s): Required Intervention