BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADICAL-7 HANDHELD

    MDR report key: 5902507 · Received August 24, 2016

    Report

    Report Number
    2031172-2016-00928
    Event Type
    Malfunction
    Date Received
    August 24, 2016
    Date of Event
    August 1, 2016
    Report Date
    August 2, 2016
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K140188
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS INDICATED THAT NO PRODUCT IS BEING RETURNED. THERE WERE NO REPORTED ISSUES WITH THE MASIMO DEVICE. PICTURES WERE MADE AVAILABLE TO MASIMO FOR REVIEW AND THE EVALUATION IS CURRENTLY UNDERWAY. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE SUBMITTED. NO PATIENT INCIDENT WAS REPORTED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT RETURN PRODUCT FOR EVALUATION, HOWEVER, BASED ON CUSTOMER DETAILS PROVIDED IT APPEARS THAT THE DEVICE SETUP WAS AT THE WEIGHT THRESHOLD FOR THE GCX ARTICULATING ARM OF (B)(6) LBS. THE RADICAL-7 WEIGHS (B)(6) LBS. ADDITIONAL FORCES THROUGH USER INTERACTION, PHYSICAL EXERTION, AND CABLE TENSION INCREASED THE OVERALL WEIGHT ABOVE (B)(6) LBS BASED ON CUSTOMER DETAILS. THE CUSTOMER NOTED THAT A SCREW WAS MISSING FROM THE MOUNTING BRACKET, WHICH WOULD REDUCE THE MAX WEIGHT THRESHOLD OF THE GCX ARTICULATING ARM, COMPOUNDING THE BREAK FAILURE. THE FAILURE OF BROKEN GCX ARTICULATING ARM WAS DUE TO A COMBINATION OF OVER-WEIGHTING OF THE ARM AND A MISSING MOUNTING SCREW. THE CUSTOMER COMPLAINT COULD NOT BE DIRECTLY CONFIRMED OR INVESTIGATED AS THE PRODUCT WAS NOT RETURNED TO MASIMO. THE CUSTOMER COMPLAINT DOES NOT APPEAR TO RELATE DIRECTLY TO MASIMO PRODUCTS, BUT TO THE UTILIZATION OF GCX ARTICULATING ARM IN MASIMO INSTALLATION AT CUSTOMER SITE.

    Additional Manufacturer Narrative · 1

    SHOULD BE "(B)(6) YR", CORRECTED DATA: WAS "(B)(6) 2016" SHOULD BE "(B)(6) 2016".

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INCIDENT HAD OCCURRED THAT MORNING IN (B)(6). A RADICAL-7 (WITH A V-BLOCK KIT), PHILIPS MODULE RACK, GCX ARTICULATING ARM BRACKET, AND GCX 12 INCH DOWNPOST HAD FALLEN ONTO A PATIENT'S BED. THE PATIENT WAS SITTING IN A CHAIR AT THE TIME. THE RADICAL-7 HAD BEEN BRACKETED TO THE PHILIPS MONITORS IN (B)(6) 2015 BY A MASIMO INSTALLER TO PROVIDE SATSHARING OPTION SO ICU STAFF COULD UTILIZE THE E1 SENSORS. MASIMO INSTALLER HAD ATTACHED A V-BLOCK KIT TO THE RADICAL-7, REPLACED THE ORIGINAL 6 INCH DOWNPOST WITH A 12 INCH GCX DOWNPOST AND BRACKED THE RADICAL-7 HORIZONTALLY UNDER THE PHILIPS MONITOR AND ABOVE THE PHILIPS MODULE RACK. THE 12 INCH GCX DOWNPOST IS ATTACHED TO THE GCX ARTICULATING ARM WITH 3 SCREWS PROVIDED WITH THE DOWNPOST. THE DOWNPOST IS METAL, BUT THE OPPOSITE SIDE OF THE ATTACHMENT IS PLASTIC. PART OF THIS PLASTIC BROKE APART WHICH, ACCORDING TO BIOMED, IS WHAT CAUSED THE BRACKETS WITH THE RADICAL-7 TO FALL. BIOMED HAD NOTICED THAT ONE SCREW HAD BEEN MISSING. THEY CHECKED ALL OTHER ROOMS WHERE RADICAL-7 UNITS HAD BEEN BRACKETED THIS WAY AND FOUND 5 OTHER ROOMS ON THE 3RD FLOOR WITH ONE MISSING SCREW, BUT NONE WERE MISSING ON THE 4TH FLOOR. BIOMED CONTACTED GCX AND VERIFIED THAT MASIMO HAD USED THE CORRECT MOUNTING EQUIPMENT FOR THIS USE. GCX ALSO INFORMED LJ BIOMED THAT THEY DO NOT USE A MATERIAL SIMILAR TO "LOCTITE" ON THEIR SCREWS. THE GCX ARTICULATING ARM HAS A WEIGHT LIMIT OF 40LBS. BIOMED WEIGHED THE RADICAL-7 WITH BRACKET, THE MODULE RACK, AND MONITOR AND CONFIRMED IT WEIGHED 40LBS. NO CONSEQUENCES OR IMPACT TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552243 RADICAL-7 HANDHELD OXIMETER DQA MASIMO CORPORATION 9500

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR