BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESIGNS VM 4 PATIENT MONITOR

    MDR report key: 2820587 · Received October 4, 2012

    Report

    Report Number
    1218950-2012-03309
    Event Type
    Malfunction
    Date Received
    October 4, 2012
    Report Date
    September 10, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K052707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION REGARDING THIS INCIDENT 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 THAT THE AUDIO FAILED WHEN THE MONITOR WAS POWERED ON. THE CUSTOMER STATED THAT THERE WAS NO SOUND AT ALL. 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