EECP THERAPY SYSTEM MODEL TS3 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2002-10-11 for EECP THERAPY SYSTEM MODEL TS3 * manufactured by Vasomedical, Inc..

Event Text Entries

[251014] Twenty-nine minutes into the patient's thirteenth treatment, the patient complained of shortness of breath. Chest x-ray taken at office showed pulmonary edema. Two doses of lasix was administered. The patient was admitted to the hospital for observation and lasix management.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2435300-2002-00010
• MDR Report Key: 421846
• Report Source: 05,06
• Date Received: 2002-10-11
• Date of Report: 2002-10-11
• Date of Event: 2002-09-26
• Date Mfgr Received: 2002-09-26
• Device Manufacturer Date: 2002-02-01
• Date Added to Maude: 2002-10-17
• 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: 0
• 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 MODEL TS3
• Generic Name: DEVICE, COUNTER-PULSATING, EXTERNAL
• Product Code: DRN
• Date Received: 2002-10-11
• 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: 410897
• 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	2002-10-11