BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO BOX DL

    MDR report key: 53658 · Received November 22, 1996

    Report

    Report Number
    2050001-1996-00032
    Event Type
    Malfunction
    Date Received
    November 22, 1996
    Date of Event
    November 1, 1996
    Report Date
    November 20, 1996
    Manufacturer
    SENSORMEDICS CORP.
    Product Code
    JEH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN THE MODEL 6200, A CAPACITOR ON THE CO2 ANALYZER ASSEMBLY BURNED UP. THERE WERE NO INJURIES AND NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTO BOX DL BODY PLETHYSMOGRAPH JEH SENSORMEDICS CORP. 6200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA