ENHANCED EXTERNAL COUNTERPULSATION LUMENAIR *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2006-02-07 for ENHANCED EXTERNAL COUNTERPULSATION LUMENAIR * manufactured by Vasomedical, Inc..

Event Text Entries

[395421] Pt arrived for treatment session #29 with increased shortness of breath and atypical chest pain. Two nitro were taken, breath sounded coarse. Treatment was started. Pt only tolerated 8 minutes of the treatment, when his heart rate increased to 103 and he experienced chest pain and wheezing. Pt taken to er.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2435300-2006-00001
• MDR Report Key: 672865
• Report Source: 05,07
• Date Received: 2006-02-07
• Date of Report: 2006-02-07
• Date of Event: 2006-01-30
• Date Mfgr Received: 2006-02-02
• Device Manufacturer Date: 2005-04-01
• Date Added to Maude: 2006-02-10
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Manufacturer Contact: THOMAS VARRICCHIONE
• Manufacturer Street: 180 LINDEN AVE.
• Manufacturer City: WESTBURY NY 11590
• Manufacturer Country: US
• Manufacturer Postal: 11590
• Manufacturer Phone: *
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ENHANCED EXTERNAL COUNTERPULSATION
• Generic Name: DEVICE, COUNTER-PULSATING, EXTERNAL
• Product Code: DRN
• Date Received: 2006-02-07
• Model Number: LUMENAIR
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: N
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 662180
• Manufacturer: VASOMEDICAL, INC.
• Manufacturer Address: 180 LINDEN AVE. WESTBURY NY 11590 US
• Baseline Brand Name: ENHANCED EXTERNAL COUNTERPULSATION
• Baseline Generic Name: DEVICE, COUNTER-PULSATING, EXTERNAL
• Baseline Model No: LUMENAIR
• Baseline Catalog No: *
• Baseline ID: *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization	2006-02-07