EECP THERAPY SYSTEM MODEL TS3 NA

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 2002-05-08 for EECP THERAPY SYSTEM MODEL TS3 NA manufactured by Vasomedical, Inc..

Event Text Entries

[229552] Pt arrived for the first treatment session tense, 20 seconds into the first 60 minute eecp session, the pt experienced panic, complained of difficulty breathing, and jumped off the table before being disconnected. After all cables and cuffs were removed, the pt was seated in a chair. Over the ensuing few minutes pt became more short of breath and began to evidence frothy sputum; the pt's skin color was gray. At that point, the pt vomitted and sebsequently pt's skin color improved and blood pressure was measured as 110/70. Shortly thereafter, "seizure" activity started progressing to a cardiopulmonary emergency. Cpr was administered, but the pt did not regain consciousness. Later, the pt was declared dead at the hosp emergency room.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2435300-2002-00004
MDR Report Key393629
Report Source07
Date Received2002-05-08
Date of Report2002-05-07
Date of Event2002-04-10
Date Mfgr Received2002-04-22
Device Manufacturer Date2001-08-01
Date Added to Maude2002-05-14
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
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 MODEL TS3
Generic NameDEVICE, COUNTER-PULSATING, EXTERNAL
Product CodeDRN
Date Received2002-05-08
Model NumberTS3
Catalog NumberNA
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key382652
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. Death 2002-05-08

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