BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTILATOR

    MDR report key: 1352013 · Received March 25, 2009

    Report

    Report Number
    MW5010479
    Event Type
    Injury
    Date Received
    March 25, 2009
    Date of Event
    March 19, 2009
    Report Date
    March 25, 2009
    Manufacturer
    SIEMENS MEDICAL SYSTEMS INC
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    VENTILATOR, MAQUET SERVO-I OXYGEN SENSOR FAILURE. MANUFACTURER ADMITS TO KNOWING OF A BAD BATCH - LOT NUMBER, 01-09 -0109 - OF O2 -OXYGEN- CELL PROBLEMS, AND OFFERS FREE EXCHANGE. O2 CELL FAILED WHILE ON A PATIENT REQUIRING THE VENTILATOR BE TAKEN OUT OF SERVICE. DATES OF USE: 2009. DIAGNOSIS: RESPIRATORY DISTRESS. EVENT REAPPEARED AFTER REINTRODUCTION: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTILATOR RESPIRATORY VENTILATOR CBK SIEMENS MEDICAL SYSTEMS INC 6487800
    2 OXYGEN CELL PART OXYGEN SENSOR DQA MAQUET 01-9-0109

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Life Threatening