MAUDE Adverse Event Report: NEUROTHERM INC NEUROTHERM RFA MACHINE; GENERATOR, LESION, RADIOFREQUENCY

Model Number NT2000

Device Problems Device Inoperable (1663); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 07/23/2014

Event Type  malfunction  

Event Description

Both machines kept malfunctioning during the procedure.First the old neurotherm machine which was switched to the new neurotherm machine.Both would not work.Both located in sterile core of mob.

• Brand Name: NEUROTHERM RFA MACHINE
• Type of Device: GENERATOR, LESION, RADIOFREQUENCY
• Manufacturer (Section D): NEUROTHERM INC; 600 research dr ste 1; wilmington MA 01887
• MDR Report Key: 3978995
• MDR Text Key: 18572961
• Report Number: 3978995
• Device Sequence Number: 1
• Product Code: GXD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Invalid Data
• Type of Report: Initial
• Report Date: 07/23/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: NT2000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR