BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTA TRAK I

    MDR report key: 91660 · Received May 14, 1997

    Report

    Report Number
    2050001-1997-00064
    Event Type
    Malfunction
    Date Received
    May 14, 1997
    Date of Event
    April 21, 1997
    Report Date
    May 13, 1997
    Manufacturer
    SENSORMEDICS CORP.
    Product Code
    BZC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    WHEN THE DELTA TRAK WAS FIRST TURNED ON, AFTER A LONG PERIOD OF NON-USE, IT SMELLED AS IF SOMETHING WAS HOT OR BURNING. THE DELTA TRAK WAS TURNED OFF. THERE WERE NO PATIENTS INVOLVED AND THERE WERE NO INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTA TRAK I METABOLIC MEASUREMENT SYSTEM BZC SENSORMEDICS CORP. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA