EECP THERAPY SYSTEM TS3 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2005-01-21 for EECP THERAPY SYSTEM TS3 * manufactured by Vasomedical, Inc..

Event Text Entries

[346907] This adverse event involved a patient that went to the er on 1/2005 for exacerbatation of chf symptoms. The patient was not admitted. The next day the patient received 9 minutes of eecp therapy before complaining of chest pain unrelieved with three nitroglycerin tablets. The patient was transported to the er and admitted for three days. While an inpatient, a catheterization was performed.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2435300-2005-00001
• MDR Report Key: 566900
• Report Source: 07
• Date Received: 2005-01-21
• Date of Report: 2005-01-21
• Date of Event: 2005-01-07
• Date Mfgr Received: 2005-01-07
• Device Manufacturer Date: 2001-11-01
• Date Added to Maude: 2005-01-25
• 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: 5169974600
• 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: EECP THERAPY SYSTEM
• Generic Name: DEVICE, COUNTER-PULSATING, EXTERNAL
• Product Code: DRN
• Date Received: 2005-01-21
• Model Number: TS3
• 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: 556689
• Manufacturer: VASOMEDICAL, INC.
• Manufacturer Address: 180 LINDEN AVE. WESTBURY NY 11590 US
• Baseline Brand Name: EECP THERAPY SYSTEM
• Baseline Generic Name: EECP
• Baseline Model No: TS3
• Baseline Catalog No: NA
• Baseline ID: NA
• Baseline Device Family: DEVICE, COUNTER-PULSATING, EXTERNAL
• Baseline Shelf Life [Months]: NA
• Baseline PMA Flag: N
• Baseline 510K PMN: Y
• Premarket Notification: K003469
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: N

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization	2005-01-21