BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METABOLIC MEASUREMENT CART

    MDR report key: 56444 · Received December 6, 1996

    Report

    Report Number
    2050001-1996-00040
    Event Type
    Malfunction
    Date Received
    December 6, 1996
    Date of Event
    November 13, 1996
    Report Date
    December 6, 1996
    Manufacturer
    SENSOR MEDICS CORP.
    Product Code
    BZC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE SETTING UP THE MODEL 2900, THE USER OBSERVED THAT THE CO2 ANALYZER ZERO AND SPAN COULD NOT BE CALIBRATED. IT WAS DETERMINED THAT A COMPONENT ON THE CO2 ANALYZER HAD BURNT. THERE WERE NO PTS INVOLVED AND THERE WERE NO INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 METABOLIC MEASUREMENT CART METABOLIC MEASUREMENT SYSTEM BZC SENSOR MEDICS CORP. 2900 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA