BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE MULTI MEASUREMENT SERVER X2

    MDR report key: 2863824 · Received November 2, 2012

    Report

    Report Number
    9610816-2012-00464
    Event Type
    Malfunction
    Date Received
    November 2, 2012
    Report Date
    October 16, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K071426
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE DEVICE ISSUED A SPEAKER MALFUNCTION. NO PT HARM WAS REPORTED. SPEAKER MALFUNCTION INOP CONFIRMED THE PROBLEM. A PHILIPS FIELD SERVICE ENGINEER (FSE) CONFIRMED THAT THE SPEAKER WAS NOT CORRECTLY CONNECTED AND THE DEVICE SHOWS A "SPEAKER MALFUNC" INOP AND THE FAILURE WAS FOUND IN THE HOSPITALS' BIO-MED SHOP. WHEN THERE IS A LOSS OF AUDIO, THE DEVICE IS DESIGNED (AS DOCUMENTED IN THE RISK MGMT SUMMARY (RMS)) TO GENERATE A "SPEAKER MALFUNCT." 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 (INTELLIVUE X2 MULTI-MEASUREMENT MODULE, INSTRUCTIONS FOR USE, PART NUMBER 453564208381,) DESCRIBES PERSONAL SURVEILLANCE: "WARNING. DO NOT RELY EXCLUSIVELY ON THE AUDIBLE ALARM SYSTEM 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 BOTH 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 HOSP PROTOCOL, AND/OR TO TROUBLESHOOT THE MONITOR. THE VISUAL INOP, TOGETHER WITH THE ABOVE PRODUCT LABELING, IS CONSIDERED AS A SUFFICIENT MITIGATION OF RISK FROM A LOSS OF AUDIO. DESPITE THIS, PHILIPS HEALTHCARE HAS A POLICY TO REPORT LOOS OF AUDIO IN ABUNDANT CAUTION. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL 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. NO PT HARM WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1