ENHANCED EXTERNAL COUNTERPULSATION TS3 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-02-18 for ENHANCED EXTERNAL COUNTERPULSATION TS3 * manufactured by Vasomedical, Inc..

Event Text Entries

[393940] Nine minutes into pt's first treatment session, pt developed acute onset of sob and chest pain. Treatment stopped, physician called, iv started, o2 given, iv morphine and lasix given, ems called. Pt coded and required resuscitation enroute. Resuscitation efforts continued until er. Admitted with chf and pulmonary edema. Pt expired eight days later while still an in-patient.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1034733
• MDR Report Key: 576714
• Date Received: 2005-02-18
• Date of Report: 2005-02-14
• Date of Event: 2005-02-08
• Date Added to Maude: 2005-03-02
• 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: 3
• 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: ENHANCED EXTERNAL COUNTERPULSATION
• Generic Name: DEVICE, EXTERNAL, COUNTER-PULSATING
• Product Code: DRN
• Date Received: 2005-02-18
• 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: 556689
• Manufacturer: VASOMEDICAL, INC.
• Manufacturer Address: * WESTBURY NY * 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. Death; 2. Hospitalization	2005-02-18