BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EECP

    MDR report key: 277921 · Received May 10, 2000

    Report

    Report Number
    2435300-2000-00001
    Event Type
    Injury
    Date Received
    May 10, 2000
    Date of Event
    April 10, 2000
    Report Date
    May 3, 2000
    Manufacturer
    VAMED MEDICAL INSTRUMENTS CO. LTD
    Product Code
    DRN
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT INITIAL ASSESSMENT WITH NORMAL VITAL SIGNS AND LUNGS CLEAR TO AUSCULTATION. PT'S DIASTOLIC AUGMENTATION RATIOS WERE ABOUT 0.3-0.4 AT 0.03 MPA. AT 40 MINS. INTO TREATMENT PT DEVELOPED RESPIRATORY DISTRESS. TREATMENT STOPPED, ASSESSED WITH WHEEZING AND PULMONARY RALES THROUGHOUT. DR. ASSESSED PT AND ORDERED 40MG IV LASIX ADMIN WITH 4L 02. ADMITTED TO HOSP (ICU) WITH PULMONARY EDEMA. PT RULED IN FOR A NON-Q WAVE MI TWO DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EECP EXTERNAL COUNTERPULSATION DRN VAMED MEDICAL INSTRUMENTS CO. LTD MC2 98006

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization 1. ATENOLOL 50 MG,| 10. AMARYL 2MG,| 5. LIPITOR 20 MG,| 6. NORVASC 5MG,| 7. ACCUPRIL 40MG,| 8. FUROSEMIDE 40MG,| 9. AVANDIA 8MG,| 4. VIT C 1000,| 11. GLUCOPHAGE 500MG| 12. ASPIRIN 81MG| 13. IMDUR 120MG.| 2. VIT E 800 UNITS,| 3. VIT B-COMPLEX,