BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MP70 INTELLIVUE PATIENT MONITOR

    MDR report key: 2243804 · Received July 29, 2011

    Report

    Report Number
    9610816-2011-00442
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Report Date
    July 15, 2011
    Manufacturer
    PHILIPS MED SYSTEMS
    Product Code
    DSI
    PMA / PMN Number
    K021300
    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 CLINICIANS REPORTED THAT AN AUDIBLE "ALARMS" DID NOT OCCUR WHEN USING THE OVERVIEW BED TO BED FEATURE. RISK ANALYSIS: BASED ON PRODUCT LABELING THAT SUPPORTS THAT CARE GROUP "ALARMING" MAY FUNCTION AS A PRIMARY MEANS OF ALARM NOTIFICATION IN SOME CIRCUMSTANCES, WE WILL CONSIDER THAT ABSENT CARE GROUPS "ALARMS" COULD LEAD TO A DELAY IN TREATMENT OF A PT. ROOT CAUSE - USER KNOWLEDGE. PER COMPLAINT DESCRIPTION: INFORMED USER, ONLY OVERVIEW PROMPT TONES OCCURS AT THE BEDS WITHIN THE CARE GROUP. THE CLINICIANS HAD BEEN UNDER THE IMPRESSION THAT CARE GROUP ALARM OVERVIEW TONES WOULD BE IDENTICAL TO ALARMING AUDIO FROM THE PATIENTS' BEDSIDE MONITOR. TWO CLINICAL SPECIALISTS INFORMED THIS BIOMED THAT ONLY THE OVERVIEW PROMPT TONE OCCURS AT THE BEDSIDE NOT THE ACTUAL ALARM. NO PRODUCT MALFUNCTION WAS IDENTIFIED. NO FURTHER RELATED CALLS HAVE BEEN LOGGED BY THE CUSTOMER FOR THIS ISSUE. CONFIGURATION OF OVERVIEW ALARMING IS ADEQUATELY DESCRIBED IN THE CENTRAL STATION CONFIGURATION GUIDE. THIS ISSUE IS CONSIDERED AS ONLY A USER APPLICATION SUPPORT ISSUE. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED. PER OUR LABELING, INSTRUCTIONS FOR USE, PART NUMBER M8000-9001K, REV H.0, PAGE 132: CARE GROUP ALARMS. CHANGES IN THE ALARM STATUS OF BEDS IN A CARE GROUP ARE ANNOUNCED VISUALLY AND AUDIBLY AT ALL OTHER BEDS IN THE SAME CARE GROUP. THE VISUAL AND AUDIBLE INDICATORS USED DEPEND ON THE MONITOR AND INFO CENTER CONFIGURATION. WHEN AN ALARM IS DETECTED AT ANOTHER BED IN THE CARE GROUP, THE ALARM STATUS IS SHOWN IN THE CARE GROUP OVERVIEW BAR AS AN ICON. A MESSAGE INFORMING YOU ABOUT THE CARE GROUP ALARM IS SHOWN IN THE MONITOR STATUS LINE. IF CONFIGURED, THE OTHER BED WINDOW, THE ALARMING BEDS WINDOW OR THE MY CARE GROUP WINDOW MAY POP UP ON THE SCREEN (IF AUTOMATIC ALARM NOTIFICATION IS ENABLED AT THE BEDSIDE MONITOR AND AT THE INFO CENTER). THE AUTOMATIC ALARM NOTIFICATION IS SUPPRESSED WHEN A WINDOW, MENU OR POP-UP KEYS ARE SOLVE. CONFIGURED, AN AUDIBLE STATUS CHANGE NOTIFICATION IS ISSUED. THE TONE TYPE AND VOLUME CAN BE CONFIGURED. HAZARD ANALYSIS - THE INFO PROVIDED RELATED TO THIS SITUATION DOES NOT SUPPORT THAT THERE IS A SYSTEMIC PROBLEM OR DESIGN OR LABELING MALFUNCTION. OR ANY HEALTH RISK. TRENDING FOR THIS SITUATION WILL BE DONE ON A PERIODIC BASIS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT OVERVIEW BEDS WERE NOT PROVIDING AUDIBLE ALARMS. NO PT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MP70 INTELLIVUE PATIENT MONITOR DSI PHILIPS MED SYSTEMS M8007A

    Patients

    Seq Age Sex Outcome Treatment
    1