MAUDE Adverse Event Report: NUCLETRON MICROSELECTRON MHDR DIGITAL; SYSTEM, APPLICATOR, RADIONUCLIDE, REMOTE-CONTROLLED

Model Number DIGITAL

Device Problem Application Program Problem: Dose Calculation Error (1189)

Patient Problem Radiation Overdose (1510)

Event Date 08/29/2014

Event Type  Injury  

Event Description

Information derived from the nrc report: the user planned the treatment time to 168 seconds for the associated source strength.The software calculated the treatment time (300 seconds) for the current source strength.The prescribed dose of 600 cgy for that fraction was higher than the user intended and this was not noticed by the user.

Manufacturer Narrative

This is the manufacturer's final report.Device not returned to manufacturer.

• Brand Name: MICROSELECTRON MHDR DIGITAL
• Type of Device: SYSTEM, APPLICATOR, RADIONUCLIDE, REMOTE-CONTROLLED
• Manufacturer (Section D): NUCLETRON; waardgelder 1; veenendaal, ; NL
• Manufacturer Contact: linac house; fleming way; crawley, west sussex RH10 -9RR
• MDR Report Key: 4116580
• MDR Text Key: 4837616
• Report Number: 9611894-2014-00002
• Device Sequence Number: 1
• Product Code: JAQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092804
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 09/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DIGITAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2014
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Other