BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VM8: MICROSTREAM CO2

    MDR report key: 2241690 · Received September 2, 2011

    Report

    Report Number
    1218950-2011-01323
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Report Date
    April 19, 2011
    Manufacturer
    PHILIPS HEALTHCARE - ANDOVER
    Product Code
    MHX
    PMA / PMN Number
    K052707
    Removal / Correction Number
    Z-0372-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED A SPEAKER MALFUNCTION IN THE VM8 SURESIGNS PT MONITOR. THE FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SITE AND REPLACED THE SPEAKER ASSEMBLY TO RESTORE THE DEVICE TO PROPER OPERATION. THE SERIAL NUMBER OF THE MONITOR DESIGNATED IN THIS COMPLAINT IS INCLUDED IN THE LIST OF MONITORS AFFECTED BY THE FIELD SAFETY NOTICE (B)(4) CREATED TO ALERT CUSTOMERS OF A POTENTIAL PREMATURE SPEAKER FAILURE. THE ACTION REQUIRED TO BE TAKEN BY THE CUSTOMER TO PREVENT PREMATURE SPEAKER FAILURE IS TO PERFORM THE SOFTWARE UPGRADE SPECIFIED IN THE FIELD CHANGE ORDER (B)(4). ONCE THE SOFTWARE UPGRADE HAS BEEN COMPLETED ON THE AFFECTED MONITORS, THE CUSTOMER IS REQUIRED TO RETURN A COMPLETED MEDICAL DEVICE CORRECTION CONFIRMATION (MDCC) FORM. NO COMPLETED FORM HAS BEEN RECEIVED BY THE CUSTOMER FOR THIS MONITOR AS OF (B)(6) 2011. THE REPORTED FAILURE IS BEING CONSIDERED AS PART OF THE PROBLEM PREVIOUSLY INVESTIGATED AND ADDRESSED IN (B)(4). THE FDA WAS NOTIFIED OF THIS FIELD ACTION BY PHILIPS HEALTHCARE ON 23 NOV 2009. NO FURTHER INVESTIGATION/ACTION IS WARRANTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WAS A LOSS OF AUDIO. NO PT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VM8: MICROSTREAM CO2 MHX PHILIPS HEALTHCARE - ANDOVER 863066

    Patients

    Seq Age Sex Outcome Treatment
    1