BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESIGNS VM 4 PATIENT MONITOR

    MDR report key: 2514768 · Received March 22, 2012

    Report

    Report Number
    1218950-2012-00973
    Event Type
    Malfunction
    Date Received
    March 22, 2012
    Report Date
    February 29, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K052707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE MONITOR WAS NOT PROVIDING AUDIBLE ALARMS. NO PATIENT HARM WAS REPORTED. THE PHILIPS RESPONSE CENTER ENGINEER (RCE) HELPED THE CUSTOMER THROUGH THE AUDIO TEST AND THE DEVICE PASSED ALL TESTING. THE RCE ALSO EXPLAINED DIFFERENT OPERATING MODES AND DIFFERENT ALARMS. THE CUSTOMER WAS SATISFIED. ALL INFORMATION INDICATES THAT THERE WAS NO MALFUNCTION. THE DEVICE LABELING (INSTRUCTIONS FOR USE/IFU) ADEQUATELY DESCRIBES AVAILABLE ALARM FUNCTIONS. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE MONITOR WAS NOT PROVIDING AUDIBLE ALARMS. NO PATIENT HARM WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1