MAUDE Adverse Event Report: MIRION TECHNOLOGIES (CAPINTEC), INC. CAPTUS 4000E; THYROID UPTAKE SYSTEM

Model Number	5430-301542
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/19/2019
Type of Reportable Event	Malfunction
Event or Problem Description
On 9/19/19 end user contacted capintec to report that the collimator fell off a captus 4000e system, s/n (b)(4).User was performing qc on the system, and found the collimator difficult to turn.Continuing to move the collimator caused it to fall off the arm.The fall was broken by the cable.No injury occurred.

• Brand Name: CAPTUS 4000E
• Common Device Name: THYROID UPTAKE SYSTEM
• Manufacturer (Section D): MIRION TECHNOLOGIES (CAPINTEC), INC.; 7 vreeland road; florham park NJ 07932
• MDR Report Key: 9166032
• Report Number: 2518443-2019-00002
• Device Sequence Number: 16690232
• Product Code: IZD
• UDI-Device Identifier: 00859942006102
• UDI-Public: 00859942006102
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: CLASS I
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 5430-301542
• Device Catalogue Number: 5430-301542
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/19/2019
• Initial Report FDA Received Date: 10/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1