BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE MULTI MEASUREMENT SERVER X2

    MDR report key: 3000052 · Received January 14, 2013

    Report

    Report Number
    9610816-2013-00017
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Report Date
    December 19, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K071426
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED X2 IS DISPLAYING SPEAKER MALFUNCTION ERROR. SPEAKER MALFUNCTION INOP CONFIRMED THE PROBLEM. NO PATIENT HARM WAS REPORTED. WHEN THERE IS A LOSS OF AUDIO, THE DEVICE IS DESIGNED (AS DOCUMENTED IN THE RISK MANAGEMENT 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 PATIENT. THE IMPORTANCE OF USING THE MONITORING EQUIPMENT IN CONJUNCTION WITH CLOSE PERSONAL OBSERVATION OF THE PATIENT IS STATED IN THE PRODUCT LABELING. THE LABELING (INTELLIVUE X2 MULTI-MEASUREMENT MODULE, INSTRUCTIONS FOR USE, PART NUMBER (B)(4), PAGE 57) DESCRIBES PERSONAL SURVEILLANCE: "WARNING DO NOT RELY EXCLUSIVELY ON THE AUDIBLE ALARM SYSTEM FOR PATIENT MONITORING. ADJUSTMENT OF ALARM VOLUME TO A LOW LEVEL OR OFF DURING PATIENT MONITORING MAY RESULT IN PATIENT DANGER. REMEMBER THAT THE MOST RELIABLE METHOD OF PATIENT 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 A SUFFICIENT MITIGATION OF RISK FROM A 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 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 X2 IS DISPLAYING SPEAKER MALFUNCTION ERROR. SPEAKER MALFUNCTION INOP CONFIRMED THE PROBLEM. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20523 INTELLIVUE MULTI MEASUREMENT SERVER X2 MHX PHILIPS MEDICAL SYSTEMS M3002A

    Patients

    Seq Age Sex Outcome Treatment
    1