BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESIGNS VS3 PATIENT MONITOR

    MDR report key: 3100016 · Received April 26, 2013

    Report

    Report Number
    1218950-2013-01500
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Report Date
    April 2, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K082280
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS DEEMED REPORTABLE SINCE PHILIPS DOES NOT HAVE ENOUGH DATA TO VERIFY THAT THERE WAS NO SOUND COMING FROM THE SPEAKER. IN AN ABUNDANCE OF CAUTION WE WILL REPORT AUDIO LOSS EVEN THOUGH A VISUAL WARNING IS PROVIDED AND PRODUCT LABELING STATES: WARNING: NEVER PAUSE AN AUDIBLE ALARM OR DECREASE THE ALARM VOLUME IF THIS COULD COMPROMISE PATIENT SAFETY. DO NOT RELY EXCLUSIVELY ON THE AUDIBLE ALARM SYSTEM FOR PATIENT MONITORING. THE MOST RELIABLE METHOD OF PATIENT MONITORING REQUIRES CORRECT OPERATION OF THE MONITOR AND CLOSE OBSERVATION OF THE PATIENT. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A MONITOR SPEAKER MALFUNCTION. NO PATIENT HARM WAS REPORTED. THIS COMPLAINT IS DEEMED REPORTABLE SINCE PHILIPS DOES NOT HAVE ENOUGH DATA TO VERIFY THAT THERE WAS NO SOUND COMING FROM THE SPEAKER. IN AN ABUNDANCE OF CAUTION WE WILL REPORT AUDIO LOSS EVEN THOUGH A VISUAL WARNING IS PROVIDED AND PRODUCT LABELING STATES: WARNING: NEVER PAUSE AN AUDIBLE ALARM OR DECREASE THE ALARM VOLUME IF THIS COULD COMPROMISE PATIENT SAFETY. DO NOT RELY EXCLUSIVELY ON THE AUDIBLE ALARM SYSTEM FOR PATIENT MONITORING. THE MOST RELIABLE METHOD OF PATIENT MONITORING REQUIRES CORRECT OPERATION OF THE MONITOR AND CLOSE OBSERVATION OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182182 SURESIGNS VS3 PATIENT MONITOR MHX PHILIPS MEDICAL SYSTEMS 863071

    Patients

    Seq Age Sex Outcome Treatment
    1