BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAINBOW R1 25L SENSOR

    MDR report key: 4863312 · Received June 19, 2015

    Report

    Report Number
    2031172-2015-00874
    Event Type
    Malfunction
    Date Received
    June 19, 2015
    Date of Event
    May 20, 2015
    Report Date
    May 20, 2015
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K081659
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATED TO INCLUDE RC PATIENT CABLE AND CORRECTED TO HP MERLIN MONITOR. INITIAL REPORTER: TELEPHONE NUMBER - (B)(6). PMA 510(K): K081659. LABELED FOR SINGLE USE: YES. USAGE OF DEVICE: UNKNOWN.

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS FOR PRODUCT RETURN AND REQUESTS FOR ADDITIONAL INFORMATION WERE MADE. THE PRODUCT HAS NOT BEEN RETURNED TO MASIMO TO ALLOW AN ANALYSIS TO BE PERFORMED. IF NEW INFORMATION IS OBTAINED OR THE PRODUCT IS RETURNED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE PROVIDED INACCURATE SPO2 READINGS. CUSTOMER REPORTED THAT THE SPO2 IS HIGHLY VARIABLE, DOES NOT WORK IN MOTION AND LOW PERFUSION AND IS NOT ALWAYS RELIABLE. IT WAS REPORTED THAT THE NUMBER 72% WAS REFERENCED BY MANY NURSES. CUSTOMER REPORTED THAT THIS ISSUE OCCURRED WITH MULTIPLE PATIENTS. NUMBER OF PATIENTS IS UNKNOWN. CUSTOMER ALSO REPORTED THAT THERE IS AN INCREASE IN FIO2 WHEN THEY ARE UNABLE TO DETERMINE THE ACCURACY OF THE PULSE OXIMETER. CLINICAL SPECIALIST REPORTED THAT THERE IS VARIABILITY IN INSTANCES WHERE THE SENSOR IS MISALIGNED OR DECOUPLED. THEY HAVE ALSO OBSERVED OCCASIONAL LOWER THAN EXPECTED SPO2, BUT ONLY IN CIRCUMSTANCES OF EXTREMELY LOW PERFUSION AND POOR SIGNAL QUALITY. THERE WERE NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399065 RAINBOW R1 25L SENSOR OXIMETER DQA MASIMO CORPORATION 2414

    Patients

    Seq Age Sex Outcome Treatment
    1 PHILLIPS MMS.| RADICAL -7,