VECTRA GENISYS *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-03-09 for VECTRA GENISYS * manufactured by Chattanooga Group Inc.

Event Text Entries

[20230146] Taken from written report: "we started the unit at the same settings as last visit. After 3 minutes, patient reported a stinging sensation. Checked contact of soundhead and settings. Paused treatment and changed setting to 1:1w/cm2 and resumed. Patient reported stinging sensation again. Discontinued ultrasound and pain stopped. Applied ice pack for 15 minutes. "======================manufacturer response for ultrasound unit, pt, vectra genisys (per site reporter). ======================unit has been returned to the vendor for repair, device failed performance tests.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2494508
• MDR Report Key: 2494508
• Date Received: 2012-03-09
• Date of Report: 2012-03-09
• Date of Event: 2012-02-23
• Report Date: 2012-03-09
• Date Reported to FDA: 2012-03-09
• Date Added to Maude: 2012-03-16
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: VECTRA GENISYS
• Generic Name: ULTRASOUND UNIT, PT
• Product Code: IMG
• Date Received: 2012-03-09
• Returned To Mfg: 2012-02-29
• Model Number: VECTRA GENISYS
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: 2 YR
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: CHATTANOOGA GROUP INC
• Manufacturer Address: 1430 DECISION STREET VISTA CA 92081 US 92081

Patients

Patient Number	Treatment	Outcome	Date
1	0		2012-03-09