BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VM8

    MDR report key: 1882538 · Received October 22, 2010

    Report

    Report Number
    1218950-2010-01998
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Report Date
    September 24, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MHX
    PMA / PMN Number
    K052707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), THE CUSTOMER REPORTED THAT THE ALARMS WERE NOT SOUNDING. NO PATIENT HARM WAS REPORTED. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION 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 ALARMS WERE NOT SOUNDING. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VM8 MHX PHILIPS HEALTHCARE 863068

    Patients

    Seq Age Sex Outcome Treatment
    1