BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VM6

    MDR report key: 1923879 · Received December 9, 2010

    Report

    Report Number
    1218950-2010-02477
    Event Type
    Malfunction
    Date Received
    December 9, 2010
    Report Date
    November 9, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MHX
    PMA / PMN Number
    K082280
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT A MONITOR FELL TO THE FLOOR. NO PATIENT HARM WAS REPORTED. THE LIMITED AVAILABLE INFORMATION IS NOT ENOUGH TO DETERMINE IF THIS REPORT REPRESENTS A MALFUNCTION OR A HEALTH RISK. 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 A MONITOR FELL TO THE FLOOR. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VM6 MHX PHILIPS HEALTHCARE 863064

    Patients

    Seq Age Sex Outcome Treatment
    1