BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RDS3 DOCKING STATION

    MDR report key: 4201507 · Received September 17, 2014

    Report

    Report Number
    2031172-2014-00191
    Event Type
    Malfunction
    Date Received
    September 17, 2014
    Date of Event
    August 8, 2014
    Report Date
    August 18, 2014
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K110028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS EVALUATED. UPON RECEIVING, A HOLE WAS OBSERVED ON THE TOP PLASTIC HOUSING OF THE RDS, APPEARING TO BE CAUSED BY BURNING AND MELTING. INTERNAL INSPECTION SHOWED NO SIGNS OF FLUID INGRESS, BUT REVEALED THAT C135 ON THE SYSTEM BOARD WAS BURNT. THE RDS WAS CONNECTED TO AC POWER WITH A DOCKED RADICAL-7 HANDHELD IN PLACE, AND THE AC INDICATOR WAS ILLUMINATED. THE HANDHELD WAS ABLE TO POWER ON AND COMMUNICATE WITH THE RDS AND WAS ABLE TO ENGAGE IN MONITORING ACTIVITIES. THE UNITS RAN FOR FOUR (4) HOURS WITH NO POWER FAILURE OBSERVED DURING THE TIME. A SERVICE HISTORY RECORD REVIEW REVEALS THAT THIS UNIT WAS IN THE FIELD FOR OVER FOUR (4) MONTHS WITH NO PREVIOUS REPORTED ISSUES PRIOR TO THIS REPORTED EVENT. UPDATED 510(K) NUMBER TO K110028. UPDATED MANUFACTURE DATE TO 03/26/2014.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO MASIMO FOR EVALUATION. WHEN THE INVESTIGATION IS COMPLETE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER FOUND A BURNT RDS-DS DOCKING STATION. NO PATIENT INCIDENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577196 RDS3 DOCKING STATION OXIMETER DQA MASIMO CORPORATION 20874

    Patients

    Seq Age Sex Outcome Treatment
    1