BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAINBOW DCI

    MDR report key: 6499937 · Received April 18, 2017

    Report

    Report Number
    2031172-2017-00466
    Event Type
    Malfunction
    Date Received
    April 18, 2017
    Date of Event
    March 26, 2017
    Manufacturer
    MASIMO - 40 PARKER
    Product Code
    DQA
    PMA / PMN Number
    K080238
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO THE LOCAL FACILITY BUT HAS NOT YET BEEN RECEIVED AT THE MAIN OFFICE FOR EVALUATION. ONCE THE DEVICE HAS BEEN RETURNED AND INVESTIGATED, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(6).

    Additional Manufacturer Narrative · 1

    THE RETURNED SENSOR WAS EVALUATED. DURING EVALUATION THE SENSOR PASSED ALL VISUAL AND FUNCTIONAL TESTING. THE SENSOR WAS DETERMINED TO BE FUNCTIONING AS DESIGNED. INITIAL REPORTER ZIP CODE EXCEEDED MAXIMUM ALLOWABLE DIGITS, ZIP CODE IS AS FOLLOWS: 634-0816, CORRECTED DATA: MODEL NUMBER CORRECTED FROM 2407 TO 24090. LOT NUMBER CORRECTED FROM 5K156 TO A15M706. DEVICE MANUFACTURE DATE CORRECTED FROM 10/10/2015 TO 11/04/0215.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SENSORS BECOME NON-FUNCTIONAL WITHIN 1 MINUTE WHEN USED WITH A PHYSIO-CONTROL DEVICE. IN THE RAD-57, THE SENSORS COULD OBTAIN THE VALUE OF HOWEVER, THE VALUE OF SPCO AND SPMET WERE HIGHER THAN PERMISSIBLE RANGE. NO PATIENT IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282462 RAINBOW DCI OXIMETER DQA MASIMO - 40 PARKER 24090 A15M706

    Patients

    Seq Age Sex Outcome Treatment
    1