BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULMONARY FUNCTION LABORATORY

    MDR report key: 47223 · Received September 5, 1996

    Report

    Report Number
    2050001-1996-90001
    Event Type
    Malfunction
    Date Received
    September 5, 1996
    Date of Event
    August 28, 1996
    Report Date
    September 4, 1996
    Manufacturer
    SENSORS MEDICS CORP
    Product Code
    BZC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    VACUUM PUMP PRESSURE RELIEF BOX WAS RATTLING. WHEN TOUCH BY AN OPERATOR, A SPARK WAS EMITTED AND THE CIRCUIT BREAKER TRIPPED. THERE WERE NO INJURIES AND NO PTS WERE REPORTED TO BE INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULMONARY FUNCTION LABORATORY PULMONARY TESTING SYSTEM BZC SENSORS MEDICS CORP 2200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA