BEUDAMED
    FDA Adverse Event Other Summary report: N

    MICRO-V ALTERNANS SENSORS

    MDR report key: 2111231 · Received May 26, 2011

    Report

    Report Number
    1225215-2011-00001
    Event Type
    Other
    Date Received
    May 26, 2011
    Date of Event
    November 2, 2010
    Report Date
    November 9, 2010
    Manufacturer
    CAMBRIDGE HEART, INC.
    Product Code
    DRX
    PMA / PMN Number
    K002230
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    THE SENSORS USED ON THE PT WERE FRESHLY OPENED (NOT RE-USED) AND DISCARDED AFTER USE. INSPECTION RECORDS FOR LOT 700922 VERIFIED THAT THE SENSORS PASSED INSPECTION.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO-V ALTERNANS SENSORS ELECTRODE, ELECTROCARDIOGRAPH DRX CAMBRIDGE HEART, INC. NA 700922

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention