ENHANCED EXTERNAL COUNTERPULSATION LUMENAIR *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2006-02-07 for ENHANCED EXTERNAL COUNTERPULSATION LUMENAIR * manufactured by Vasomedical, Inc..

Event Text Entries

[395421] Pt arrived for treatment session #29 with increased shortness of breath and atypical chest pain. Two nitro were taken, breath sounded coarse. Treatment was started. Pt only tolerated 8 minutes of the treatment, when his heart rate increased to 103 and he experienced chest pain and wheezing. Pt taken to er.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2435300-2006-00001
MDR Report Key672865
Report Source05,07
Date Received2006-02-07
Date of Report2006-02-07
Date of Event2006-01-30
Date Mfgr Received2006-02-02
Device Manufacturer Date2005-04-01
Date Added to Maude2006-02-10
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 Phone*
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameENHANCED EXTERNAL COUNTERPULSATION
Generic NameDEVICE, COUNTER-PULSATING, EXTERNAL
Product CodeDRN
Date Received2006-02-07
Model NumberLUMENAIR
Catalog Number*
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key662180
ManufacturerVASOMEDICAL, INC.
Manufacturer Address180 LINDEN AVE. WESTBURY NY 11590 US
Baseline Brand NameENHANCED EXTERNAL COUNTERPULSATION
Baseline Generic NameDEVICE, COUNTER-PULSATING, EXTERNAL
Baseline Model NoLUMENAIR
Baseline Catalog No*
Baseline ID*


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2006-02-07

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