BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESIGNS VS3 PATIENT MONITOR

    MDR report key: 2082765 · Received April 29, 2011

    Report

    Report Number
    1218950-2011-01188
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Report Date
    March 31, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MHX
    PMA / PMN Number
    K082280
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED A SPEAKER FAILURE DURING A MAINTENANCE PROCEDURE. NO PATIENT HARM WAS REPORTED. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION CONCERNING THIS EVENT 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, A SPEAKER FAILURE DURING A MAINTENANCE PROCEDURE. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURESIGNS VS3 PATIENT MONITOR MHX PHILIPS HEALTHCARE 863071

    Patients

    Seq Age Sex Outcome Treatment
    1