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

Model Number 5430-301542

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/19/2019

Event Type  malfunction  

Event 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
• Type of Device: THYROID UPTAKE SYSTEM
• Manufacturer (Section D): MIRION TECHNOLOGIES (CAPINTEC), INC.; 7 vreeland road; florham park NJ 07932
• Manufacturer (Section G): MIRION TECHNOLOGIES (CAPINTEC) INC.; 7 vreeland road; florham park NJ 07932
• Manufacturer Contact: mary yusko ; 7 vreeland drive; florham park, NJ 07932 ; 2018259500
• MDR Report Key: 9166032
• MDR Text Key: 188700598
• Report Number: 2518443-2019-00002
• Device Sequence Number: 1
• Product Code: IZD
• UDI-Device Identifier: 00859942006102
• UDI-Public: 00859942006102
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: CLASS I
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5430-301542
• Device Catalogue Number: 5430-301542
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/30/2016
• 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