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 Number2435300-2005-00001
MDR Report Key566900
Report Source07
Date Received2005-01-21
Date of Report2005-01-21
Date of Event2005-01-07
Date Mfgr Received2005-01-07
Device Manufacturer Date2001-11-01
Date Added to Maude2005-01-25
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Manufacturer ContactTHOMAS VARRICCHIONE
Manufacturer Street180 LINDEN AVE.
Manufacturer CityWESTBURY NY 11590
Manufacturer CountryUS
Manufacturer Postal11590
Manufacturer Phone5169974600
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameEECP THERAPY SYSTEM
Generic NameDEVICE, COUNTER-PULSATING, EXTERNAL
Product CodeDRN
Date Received2005-01-21
Model NumberTS3
Catalog Number*
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key556689
ManufacturerVASOMEDICAL, INC.
Manufacturer Address180 LINDEN AVE. WESTBURY NY 11590 US
Baseline Brand NameEECP THERAPY SYSTEM
Baseline Generic NameEECP
Baseline Model NoTS3
Baseline Catalog NoNA
Baseline IDNA
Baseline Device FamilyDEVICE, COUNTER-PULSATING, EXTERNAL
Baseline Shelf Life [Months]NA
Baseline PMA FlagN
Baseline 510K PMNY
Premarket NotificationK003469
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2005-01-21

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