BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAINBOW ADH SENSOR

    MDR report key: 4964037 · Received July 29, 2015

    Report

    Report Number
    2031172-2015-00976
    Event Type
    Malfunction
    Date Received
    July 29, 2015
    Date of Event
    June 29, 2015
    Report Date
    June 29, 2015
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K081659
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS HAVE BEEN MADE TO OBTAIN THE PRODUCT. THE PRODUCT INVOLVED IN THIS EVENT HAS NOT BEEN RETURNED TO DATE TO ALLOW FOR AN ANALYSIS TO BE PERFORMED. IF THE PRODUCT IS RETURNED FOR EVALUATION OR NEW INFORMATION IS OBTAINED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE INACCURATE READINGS. THE CUSTOMER ALSO STATED THE PACKAGE FOR THE RAINBOW R1 20L SENSOR INCORRECTLY DEPICTS SENSOR PLACEMENT. THE ILLUSTRATION ON THE PACKAGE SEEMS TO SHOW THE CABLE, POSITIONED ON THE UNDERSIDE OF THE FOOT. THIS ORIENTATION WOULD PLACE THE EMITTER ON THE UNDERSIDE OF THE TOE OR THUMB. THE CUSTOMER ALSO STATED THE ILLUSTRATION IS NOT CONSISTENT WITH THE ILLUSTRATION ON THE DFU WHICH SHOWS CORRECT PLACEMENT. THERE WAS NO KNOWN PATIENT IMPACT OR CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492272 RAINBOW ADH SENSOR DQA MASIMO CORPORATION 24960 A15B162

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR