BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VM8

    MDR report key: 3060104 · Received March 20, 2013

    Report

    Report Number
    1218950-2013-00964
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Report Date
    February 22, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K052707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT THE SPEAKER WAS NOT WORKING. NO PT HARM WAS REPORTED. PHILIPS IS REPORTING THIS INCIDENT AS THERE IS NOT ENOUGH DATA TO VERIFY THAT THERE WAS NO SOUND BEING EMITTED FROM THE MONITOR. IN AN ABUNDANCE OF CAUTION WE WILL REPORT AUDIO LOSS EVEN THOUGH A VISUAL ALARM WARNING IS PROVIDED AND PRODUCT LABELING STATES: WARNING: NEVER PAUSE AN AUDIBLE ALARM OR DECREASE THE ALARM VOLUME IF THIS COULD COMPROMISE PT SAFETY. DO NOT RELY EXCLUSIVELY ON THE AUDIBLE ALARM SYSTEM FOR PT MONITORING. THE MOST RELIABLE METHOD OF PT MONITORING REQUIRES CORRECT OPERATION OF THE MONITOR AND CLOSE OBSERVATION OF THE PT. THE COMPLAINT IS STILL UNDER INVESTIGATION. A F/U REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SPEAKER WAS NOT WORKING. NO PT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116611 VM8 MHX PHILIPS MEDICAL SYSTEMS 863068

    Patients

    Seq Age Sex Outcome Treatment
    1