BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE MP2

    MDR report key: 2571036 · Received May 7, 2012

    Report

    Report Number
    9610816-2012-00221
    Event Type
    Malfunction
    Date Received
    May 7, 2012
    Report Date
    April 2, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K040357
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PR#: 940601. H3, H6: THE CUSTOMER REPORTED THAT THE MONITORS WERE NOT ALARMING WHEN THE BATTER LOST POWER. NO PATIENT HARM WAS REPORTED. INITIAL COMMUNICATION WITH THE RESPONSIBLE PHILIPS FIELD SERVICE ENGINEER (FSE) REVEALED THAT THERE IS NO FURTHER INFORMATION FROM THE CUSTOMER ABOUT THE REPORTED FAILURE. PHILIPS IS UNAWARE IF THE CUSTOMER MEANT THAT, DURING USAGE OF THE MP2 WITH A BATTERY, THE DEVICE GAVE NO INOP, OR IF THE LOW BATTERY STATUS WAS NOT SHOWN ON THE MP2 AS AN INOP. THE PRODUCT LABELING, (INTELLIVUE MP2 PATIENT MONITOR, PART NUMBER 453564208621, PAGE 53), DESCRIBES 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 PER HOSPITAL PROTOCOL, AND/OR TO TROUBLESHOOT THE MONITOR. THE PRODUCT LABELING INTELLIVUE MP2 PATIENT MONITOR, INSTRUCTIONS FOR USE, PART NUMBER 453564208621, PAGE 25) DESCRIBES: "USING THE BATTERY EXTENSION: TO PROVIDE ENOUGH POWER FOR THE USE OF AN MMS EXTENSION DURING TRANSPORT, YOU CAN USE THE BATTERY EXTENSION ((B)(4)). THE BATTERY EXTENSION PROVIDES ADDITIONAL BATTERY POWER FOR SITUATIONS WHEN NO MAINS POWER IS AVAILABLE AND CAN TYPICALLY POWER THE MONITOR WITH MMS EXTENSION FOR A LEAST 6 HOURS. PAGE 26 DESCRIBES." LED INDICATORS: THE BATTERY EXTENSION HAS TWO LED INDICATORS. THE POWER LED LIGHTS GREEN WHEN THE BATTERY EXTENSION IS CONNECTED TO EXTERNAL POWER. THE BATTERY CHARGE LED GIVES BATTERY STATUS INFORMATION: TO REMOVE THE MONITOR WITH MMS EXTENSION, PRESS THE RELEASE LEVER AND PUSH THE MONITOR ACROSS TO RELEASE THE CONNECTION. LED INDICATION STATUS: EXTERNAL POWER AVAILABLE. GREEN - BATTERY FULLY CHARGED. YELLOW - BATTERY CHARGING. RED FLASHING (SHORT ON PHASE) - BATTERY MAINTENANCE REQUIRED. RED FLASHING (LONG ON PHASE) - BATTERY EXTENSION MALFUNCTION. OFF - NO BATTERY INSERTED IN THE BATTERY EXTENSION. EXTERNAL POWER NOT AVAILABLE: YELLOW FLASHING (SHORT ON PHASE) - BATTERY EXTENSION IS CHARGING THE MONITOR BATTERY (MONITOR IS SWITCHED OFF). RED FLASHING (SHORT ON-PHASE) - IF THE MONITOR IS RUNNING, THIS INDICATES VERY LOW BATTERY CHARGE (<10 MINUTES RUNNING TIME LEFT). IF THE MONITOR IS NOT RUNNING, THIS INDICATES THAT BATTERY MAINTENANCE IS REQUIRED. RED FLASHING (LONG ON-PHASE) - BATTERY EXTENSION CANNOT PROVIDE POWER TO THE MONITOR. EITHER THE BATTERY EXTENSION NEEDS CHARGING, OR IT HAS A MALFUNCTION. PAGE 73 DESCRIBES THE BATTERY INOPS AND PAGE 86 THE TELEMETRY INOPS. 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 MONITORS WERE NOT ALARMING WHEN THE BATTER LOST POWER. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTELLIVUE MP2 MHX PHILIPS MEDICAL SYSTEMS M8102A

    Patients

    Seq Age Sex Outcome Treatment
    1