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 2002-12-11 for EECP THERAPY SYSTEM MODEL TS3 * manufactured by Vasomedical Inc.

Event Text Entries

[306947] Thirty minutes into the pt's first treatment, the pt experienced sob non-productive wet cough and rales were noted on auscultation. Bp increased to 158/98, o2 saturation dropped to 76%, pulse increased from 60's to 104 bpm. Pt was placed on 6l of o2, saturation increased to 80%. Placed on non-rebreather with o2 up to 86%. Emergency service transferred pt to er. Following stabilization in er, pt was admitted to the hospital.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2435300-2002-00013
MDR Report Key435872
Report Source05,06
Date Received2002-12-11
Date of Report2002-12-10
Date of Event2002-11-04
Date Mfgr Received2002-11-04
Device Manufacturer Date2001-08-01
Date Added to Maude2003-01-06
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 Received2002-12-11
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 Key424794
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 2002-12-11

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.