BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VM8: MICROSTREAM CO2

    MDR report key: 2222341 · Received July 15, 2011

    Report

    Report Number
    1218950-2011-01985
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Report Date
    June 14, 2011
    Manufacturer
    PHILIPS HEALTHCARE - ANDOVER
    Product Code
    MHX
    PMA / PMN Number
    K052707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE MONITOR WAS DAMAGED DUE TO AN ACCIDENTAL FALL. NO PT HARM WAS REPORTED. PHILIPS IS IN THE PROCESS OF OBTAINING ADD'L INFO CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE MONITOR WAS DAMAGED DUE TO AN ACCIDENTAL FALL. NO PT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VM8: MICROSTREAM CO2 MHX PHILIPS HEALTHCARE - ANDOVER 863066

    Patients

    Seq Age Sex Outcome Treatment
    1