BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESIGNS VM 4 PATIENT MONITOR

    MDR report key: 2233220 · Received July 22, 2011

    Report

    Report Number
    1218950-2011-01888
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Report Date
    June 25, 2011
    Manufacturer
    PHILIPS HEALTHCARE - ANDOVER
    Product Code
    MHX
    PMA / PMN Number
    K052707
    Removal / Correction Number
    Z-2583-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THERE WAS A SPEAKER MALFUNCTION ERROR MESSAGE ON THE MONITOR'S DISPLAY SCREEN. NO PT HARM WAS REPORTED. IN A TWO MONTH PERIOD, PHILIPS RECEIVED A SMALL NUMBER OF COMPLAINTS REPORTING PREMATURE SPEAKER FAILURE IN THE VS3, VM4, VM6 AND VM8 SURESIGNS PT MONITORS. THESE FAILURES TRIGGERED A FORMAL INVESTIGATION INTO THE ISSUE AND THE ISSUING OF FIELD SAFETY NOTICE FSN86201239A AND FIELD CHANGE ORDER FCO86201239A. PRIOR TO THE ISSUANCE OF THE FCO, THE PHILIPS SOLUTION CENTER (SC) SHIPPED THE CUSTOMER A REPLACEMENT MAIN BOARD TO ATTEMPT TO RESOLVE THE ISSUE; HOWEVER, SUBSEQUENT SERVICE NOTES CONFIRM THAT THE MANDATORY ACTIONS REQUIRED IN THE FSN/FCO ARE BEING TAKEN FOR THIS DEVICE. THIS DEVICE HAS ALSO BEEN CONFIRMED AS BEING ON THE UNITS AFFECTED LIST (UAL) FOR THIS FCO. ON JUNE 7TH, 2011, PHILIPS HEALTHCARE NOTIFIED THE FDA OF THIS MANDATORY FIELD ACTION. NO FURTHER INVESTIGATION/ACTION IS WARRANTED AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WAS A SPEAKER MALFUNCTION ERROR MESSAGE ON THE MONITOR'S DISPLAY SCREEN. NO PT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURESIGNS VM 4 PATIENT MONITOR MHX PHILIPS HEALTHCARE - ANDOVER 863063

    Patients

    Seq Age Sex Outcome Treatment
    1