BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE MULTI MEASUREMENT SRVER X2

    MDR report key: 2953942 · Received January 14, 2013

    Report

    Report Number
    9610816-2013-00018
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Report Date
    December 21, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K071426
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SPEAKER MALFUNCTION INOP CONFIRMED THE PROBLEM. WHEN THERE IS A LOSS OF AUDIO, THE DEVICE IS DESIGNED (AS DOCUMENTED IN THE RISK MGMT SUMMARY (RMS)) TO GENERATE A "SPEAKER MALFUNCTION" INOP. IT IS CONSIDERED THAT THE INOP WOULD MAKE THE ISSUE IMMEDIATELY OBVIOUS TO USERS DURING CLOSE OBSERVATION OF THE PT. THE IMPORTANCE OF USING THE MONITORING EQUIPMENT IN CONJUNCTION WITH CLOSE PERSONAL OBSERVATION OF THE PT IS STATED IN THE PRODUCT LABELING. THE LABELING (INTELIVUE X2 MULTI-MEASUREMENT MODULE, INSTRUCTIONS FOR USE, PART NUMBER 453564208381, PAGE 57) DESCRIBES PERSONAL SURVEILLANCE: "WARNING - DO NOT RELY EXCLUSIVELY ON THE AUDIBLE ALARM SYS FOR PT MONITORING. ADJUSTMENT OF ALARM VOLUME TO A LOW LEVEL OR OFF DURING PT MONITORING MAY RESULT IN PT DANGER. REMEMBER THAT THE MOST RELIABLE METHOD OF PT MONITORING COMBINES CLOSE PERSONAL SURVEILLANCE WITH CORRECT OPERATION OF MONITORING EQUIPMENT." THIS WOULD ALLOW THE USER TO IMPLEMENT ALTERNATIVE METHODS OF MONITORING (IF NOT ALREADY APPLIED) PER HOSPITAL PROTOCOL, AND/OR TO TROUBLESHOOT THE MONITOR. THE VISUAL INOP, TOGETHER WITH THE ABOVE PRODUCT LABELING, IS CONSIDERED AS SUFFICIENT MITIGATION OF RISK FROM LOSS OF AUDIO. DESPITE THIS, PHILIPS HEALTHCARE HAS A POLICY TO REPORT A LOSS OF AUDIO, THEREFORE, THIS COMPLAINT HAS BEEN EVALUATED TO BE REPORTABLE. PHILIPS IS IN THE PROCESS OF OBTAINING ADD'L INFO 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 DEVICE ISSUED A "SPEAKER MALFUNCTION." INOP TOGETHER WITH A LOSS OF AUDIO. THERE WAS NO ALLEGATION OF A DEATH OR A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20237 INTELLIVUE MULTI MEASUREMENT SRVER X2 MHX PHILIPS MEDICAL SYSTEMS M3002A

    Patients

    Seq Age Sex Outcome Treatment
    1