BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VM6

    MDR report key: 2243894 · Received July 29, 2011

    Report

    Report Number
    1218950-2011-01980
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Report Date
    July 4, 2011
    Manufacturer
    PHILIPS HEALTHCARE - ANDOVER
    Product Code
    MHX
    PMA / PMN Number
    K082280
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT ALARMS WERE DOWN FOR THIS MONITOR. IT WAS CONFIRMED THAT THERE WAS NO AUDIO SENT FROM THE MONITOR'S SPEAKER. NO PT HARM WAS REPORTED. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL 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 ALARMS WERE DOWN FOR THIS MONITOR. IT WAS CONFIRMED THAT THERE WAS NO AUDIO SENT FROM THE MONITOR'S SPEAKER. NO PT HARM WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1