BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MASIMO CORPORATION

    MDR report key: 1534536 · Received November 11, 2009

    Report

    Report Number
    2031172-2009-00005
    Event Type
    Malfunction
    Date Received
    November 11, 2009
    Date of Event
    October 12, 2009
    Report Date
    November 9, 2009
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY OF DEVICE: THE OXIMETER C-CLAMP BRACKET (PN: 30801) IS USED IN CONJUNCTION WITH THE J-BRACKET TO MOUNT MASIMO PULSE OXIMETERS TO AN ELEVATED WALL MOUNT. BASED ON OUR INTERNAL FAILURE ANALYSIS, THE C-CLAMPS THAT WERE DAMAGED AT THIS SPECIFIC CUSTOMER SITE WERE INSTALLED IN (B)(6)2008, AND WERE FOUND TO BE BROKEN AT A WELD JOINT, WHICH SUPPORTS THE WEIGHT OF THE J-BRACKET AND MASIMO PULSE OXIMETER COMBINED. REVIEW OF THE CUSTOMER COMPLAINT HISTORY HAS SHOWN THAT THE TWO BROKEN CLAMPS ARE ISOLATED IN OCCURRENCE AND ARE THE ONLY INSTANCES OF THIS TYPE OF COMPLAINTS WERE REPORTED FROM THE SAME CUSTOMER FROM WITHIN THE SAME DEPARTMENT WITHIN A WEEK OF EACH OTHER. (B)(4). THE LIKELIHOOD OF OCCURRENCE IS ASSESSED TO BE RARE IN NATURE DUE TO THE CALCIFIED FAILURE RATE.

    Description of Event or Problem · 1

    THE C-CLAMP IS USED TO SECURE A MASIMO BEDSIDE PULSE OXIMETER TO AN ELEVATED WALL MOUNT. THE C-CLAMP WAS FOUND TO BE BROKEN ON TWO SEPARATE OCCURRENCES BY THE SAME CUSTOMER IN THE SAME DEPARTMENT. BREAKAGE OF C-CLAMP HAS LED TO THE DEVICE AND J-BRACKET FALLING FROM ITS MOUNTED LOCATION. CUSTOMER COMPLAINTS WERE EVALUATED SINCE BEGINNING OF DISTRIBUTION AND THE ISSUES REPORTED BY THIS CONSUMER WERE FOUND TO BE ISOLATED IN OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MASIMO CORPORATION C-CLAMP DQA MASIMO CORPORATION PN: 30801 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA