EECP THERAPY SYSTEM, MODEL TS3 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-12-30 for EECP THERAPY SYSTEM, MODEL TS3 * manufactured by Vasomedical, Inc..

Event Text Entries

[286202] Pt was treated with either a device identified as the eecp therapy system model ts3 with pulse oximetry and enhanced extera k020857 or the eecp therapy system, model ts3 k093469, marketed by vasomedical, inc. The device is used to treat angina, chest pains caused by restricted blood flow in the coronary arteries. Consumer was treated with this device daily for about thirty-five days. The treatment allegedly resulted in damage to their eye resulting in retinal surgery.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1027082
• MDR Report Key: 435257
• Date Received: 2002-12-30
• Date of Report: 2002-12-24
• Date Added to Maude: 2003-01-03
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: EECP THERAPY SYSTEM, MODEL TS3
• Generic Name: EXTERNAL CONTER-PULSATING DEVICE
• Product Code: DRN
• Date Received: 2002-12-30
• Model Number: TS3
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 424197
• 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. Required No Informationntervention	2002-12-30