BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE MULTI MEASURMENT SERVER X2

    MDR report key: 3031266 · Received March 5, 2013

    Report

    Report Number
    9610816-2013-00050
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Report Date
    February 20, 2013
    Manufacturer
    PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN
    Product Code
    MHX
    PMA / PMN Number
    K071426
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 (SHIPPED WITH THE DEVICE) 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 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 A SPEAKER MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94713 INTELLIVUE MULTI MEASURMENT SERVER X2 MHX PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN M3002A

    Patients

    Seq Age Sex Outcome Treatment
    1