BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FL-601-97

    MDR report key: 5351944 · Received September 8, 2004

    Report

    Report Number
    1056553-2004-00002
    Event Type
    Malfunction
    Date Received
    September 8, 2004
    Date of Event
    August 31, 2004
    Report Date
    September 7, 2004
    Manufacturer
    REMINGTON MEDICAL, INC.
    Product Code
    DSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    2

    Narratives

    Additional Manufacturer Narrative · 1

    REMINGTON MEDICAL, INC., 100% TEST FOR ELECTRICAL CONTINUITY AT OUR FACILITY. OUR CURRENT TEST DEVICE IS A MULTIMETER THAT GIVES A NUMERIC READING AND AN AUDIBLE ALARM. (B)(4).

    Description of Event or Problem · 1

    FL-601-97 DISPOSABLE EXTENSION CABLE CONNECTED ON ONE END TO PACING ELECTRODES AND ON THE OTHER END TO MEDTRONIC PACER MODEL 5348. UNABLE TO GET A READING. SWITCHED TO ANOTHER F.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FL-601-97 DISPOSABLE DSA REMINGTON MEDICAL, INC. FL-601-97 040147

    Patients

    Seq Age Sex Outcome Treatment
    1