BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADICAL

    MDR report key: 537881 · Received July 28, 2004

    Report

    Report Number
    537881
    Event Type
    Malfunction
    Date Received
    July 28, 2004
    Date of Event
    June 1, 2003
    Report Date
    May 4, 2004
    Manufacturer
    MASIMO CORP.
    Product Code
    DQA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 8/30/04: MASIMO HAS ANALYZED SEVERAL RADICAL PULSE OXIMETERS RETURNED BY CHW FOR EXHIBITING UNRELIABLE ELECTRICAL CONTACT. IN SOME CASES THE COMMUNICATION LOSS AND SUBSEQUENT NURSE CALL ALARM COULD NOT BE DUPLICATED. IN OTHER CASES THE CONDITION WAS DUPLICATED, ALTHOUGH ONLY AS A RESULT OF CONTACT BY THE USER. IN NO CASE DID MASINO FIND A RADICAL TRIGGERING A NURSE CALL ALARM WITHOUT SOME USER CONTACT. IN GENERAL IT IS NECESSARY TO PUSH AGAINST THE HANDHELD UNIT WHILE IT IS DOCKED IN THE DOCKING STATION. IN SEVERAL INSTANCES THE COMMUNICATION LOSS COULD NO LONGER BE TRIGGERED AFTER THE ELECTRICAL CONTACTS WERE CLEANED WITH ISOPROPYL ALCOHOL. IN SOME CASES REPLACING THE ELECTRICAL CONTACTS ALSO RESOLVED THE ISSUE. HOWEVER, MASIMO UNDERTOOK A REDESIGN OF THE CIRCUIT ACTIVATING THE NURSE CALL ALARM IN ORDER TO MAKE IT MORE ROBUST. THE REDESIGNED CIRCUIT WILL NOT ALLOW A NURSE CALL ALARM TO TRIGGER IF THE DOCKING STATION LOSES COMMUNICATION WITH THE HANDHELD UNIT AFTER ENOUGH TIME FOR A SINGLE RESET OF THE DOCKING STATION (ABOUT 25 SECONDS) HAS OCCURRED, ALL OTHER ALARMS WILL BE TRIGGERED AS THEY OCCUR. IN THIS CASE ANY MOMENTARY LOSS OF ELECTRICAL CONTACT BETWEEN THE HANDHELD AND THE DOCKING STATION WILL NOT CAUSE A NURSE CALL ALARM. MASIMO HAS MODIFIED SEVERAL RADICAL PULSE OXIMETERS WITH THIS CIRCUIT AND INSTALLED THEM. AS FAR AS MASIMO KNOWS NONE OF THE MODIFIED UNITS HAS CAUSED AN UNJUSTIFIED NURSE CALL ALARM. THE DEVICES ARE CURRENTLY IN USE AND WE HAVE NOT HAD ANY ADDITIONAL REPORTED ALARMS.

    Description of Event or Problem · 1

    THE MASIMO RADICAL PULSE OXIMETER CAUSES ERRONEOUS ACTIVATION OF THE NURSE CALL SYSTEM WHEN IT IS INTERFACED TO IT. THIS IS DUE TO POOR CONNECTOR DESIGN. THE RADICAL DISPLAY UNIT CAN BE DETACHED FROM IT'S DOCKING STATION AND USED AS A HANDHELD OXIMETER. WHEN RE-ATTACHED TO THE DOCKING STATION IT BECOMES A BEDSIDE MONITOR WITH AC POWER AND CAN BE CONNECTED TO THE NURSE CALL SYSTEM THROUGH THE DOCKING STATION.THE RADICAL HAS SPRING-LOADED CONTACTS BETWEEN THE DISPLAY AND THE DOCKING STATION. THESE CONTACTS ARE PRONE TO "CHATTER" DUE TO POOR CONTACT. THIS "CHATTER" CAUSES THE UNIT TO SENSE THE HANDHELD DISPLAY AS REMOVED AND TRIGGERS A CALL THROUGH THE NURSE CALL SYSTEM. THE "CHATTER" CAN OCCUR AT ANYTIME. THE "CHATTER" MAY HAPPEN WHILE THE UNIT IS SITTING UNTOUCHED OR WHEN OPERATING THE CONTROLS. THIS CAUSES STAFF TO RESPOND TO FALSE ALARMS AND MAY DESENSITIZE THEIR RESPONSE TO REAL ALARMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADICAL PULSE OXIMETER DQA MASIMO CORP. RADICAL *

    Patients

    Seq Age Sex Outcome Treatment
    1 *