BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESIGNS VS3 PATIENT MONITOR

    MDR report key: 2310334 · Received September 29, 2011

    Report

    Report Number
    1218950-2011-02671
    Event Type
    Malfunction
    Date Received
    September 29, 2011
    Report Date
    September 1, 2011
    Manufacturer
    PHILIPS HEALTHCARE - ANDOVER
    Product Code
    MHX
    PMA / PMN Number
    K082280
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED A MONITOR SPEAKER MALFUNCTION. THIS COMPLAINT IS DEEMED REPORTABLE SINCE PHILIPS DOES NOT HAVE ENOUGH DATA TO VERIFY THAT THERE WAS NO SOUND COMING FROM THE SPEAKER. 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 MONITOR SPEAKER MALFUNCTION. THIS COMPLAINT IS DEEMED REPORTABLE SINCE PHILIPS DOES NOT HAVE ENOUGH DATA TO VERIFY THAT THERE WAS NO SOUND COMING FROM THE SPEAKER. NO PATIENT HARM WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1