BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VM8

    MDR report key: 2943540 · Received January 9, 2013

    Report

    Report Number
    1218950-2013-00082
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Report Date
    December 13, 2012
    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 MONITOR SPEAKER WAS NOT WORKING. NO PT HARM WAS REPORTED. THIS COMPLAINT IS DEEMED REPORTABLE SINCE PHILIPS DOES NOT HAVE ENOUGH DATA TO VERIFY THAT THERE WAS NO SOUND COMING FROM THE SPEAKER. 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. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFO REGARDING THIS INCIDENT 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 SPEAKER WAS NOT WORKING. NO PT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13113 VM8 MHX PHILIPS MEDICAL SYSTEMS 863068

    Patients

    Seq Age Sex Outcome Treatment
    1