BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 353746 · Received September 28, 2001

    Report

    Report Number
    2518435-2001-00003
    Event Type
    Malfunction
    Date Received
    September 28, 2001
    Report Date
    September 28, 2001
    Manufacturer
    SCOTT MEDICAL PRODUCTS
    Product Code
    BXK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MEDICAL GRAPHICS CORP'S (MGC) "QA/RA" MGR, CONTACTED SCOTT MEDICAL PRODUCTS' QUALITY ENGINEER TO REPORT A PROBLEM WITH A CALIBRATION GAS STANDARD. BASED ON AN EQUIPMENT SERVICE CALL AT THE USER FACILITY, MGC HAD DETERMINED THAT A CALIBRATION GAS STANDARD, LOT NO. 116617, WAS DEFECTIVE. THE CALIBRATION GAS STANDARD WAS LABELED AS 21% OXYGEN, HOWEVER IT WAS DETERMINED TO BE APPROXIMATELY 19.7% OXYGEN. MGC WAS CALLED TO SERVICE THE CARDIO2 EQUIPMENT (CARDIOPULMONARY EXERCISE SYSTEM) BECAUSE THE PULMONARY GROUP BELIEVED THAT IT WAS NOT PROVIDING CORRECT VO2 VALUES. SMP ANALYZED A CYLINDER FROM THE SAME MANUFACTURING LOT AND CONFIRMED THE VALUE OF THE OXYGEN CONCENTRATION TO BE APPROX 19.7%. MGC COMPLETED EXPERIMENTS TO DETERMINE THE IMPACT OF USING THE 19.7% OXYGEN CALIBRATION GAS ON THE VO2 VALUES. MGC FOUND THE VALUES OF THE VO2 TO BE APPROX 21% HIGHER THAN THE "TRUE" VALUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44051 NA CALIBRATION GAS STANDARD BXK SCOTT MEDICAL PRODUCTS * 116617

    Patients

    Seq Age Sex Outcome Treatment
    1 NA