BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAINBOW RC-4

    MDR report key: 6704812 · Received July 11, 2017

    Report

    Report Number
    2031172-2017-00704
    Event Type
    Malfunction
    Date Received
    July 11, 2017
    Date of Event
    June 19, 2017
    Manufacturer
    MASIMO - 40 PARKER
    Product Code
    DQA
    UDI-DI
    00843997003193
    PMA / PMN Number
    K080238
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURING NARRATIVE: ATTEMPTS HAVE BEEN MADE TO OBTAIN THE PRODUCT. THE PRODUCT HAS NOT BEEN RETURNED TO MASIMO TO ALLOW AN ANALYSIS TO BE PERFORMED. IF THE PRODUCT IS RETURNED FOR EVALUATION OR NEW INFORMATION IS OBTAINED, A FOLLOW UP REPORT WILL BE SUBMITTED. INITIAL REPORTER ZIP CODE EXCEEDED THE MAXIMUM ALLOWABLE CHARACTERS, ZIP CODE IS AS FOLLOWS: (B)(6).

    Additional Manufacturer Narrative · 1

    THE RETURNED CABLE WAS EVALUATED. THE RETURNED CABLE PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING; HOWEVER, FAILED SOFTWARE ANALYSIS DUE TO CORRUPTED CABLE LIFE. A ¿REPLACE CABLE" ERROR MESSAGE DISPLAYED; WHICH WOULD HAVE PREVENTED THE UNIT FROM BEING ABLE TO ENGAGE IN MONITORING ACTIVITIES. A SERVICE HISTORY RECORD REVIEW REVEALS THAT THIS UNIT WAS IN THE FIELD FOR OVER ONE (1) YEAR WITH NO PREVIOUS REPORTED ISSUES PRIOR TO THIS REPORTED EVENT. INITIAL REPORTER ZIP CODE EXCEEDED THE MAXIMUM ALLOWABLE CHARACTERS, ZIP CODE IS AS FOLLOWS: (B)(6).CORRECTED DATA: (BRAND NAME) UPDATED FROM "M-LNCS DC-I" TO "RAINBOW RC-4". (MODEL#) UPDATED FROM "2501" TO "2406". (CATALOG#) UPDATED FROM "2501" TO "2406". (LOT#) UPDATED FROM "K17CGK" TO "16C3X". (UNIQUE IDENTIFIER (UDI)#) UPDATED FROM "(B)(4)" TO "NI". (DEVICE MANUFACTURE DATE) UPDATED FROM "03/08/2017" TO "03/28/2016". (PMA/510(K)#) UPDATED FROM "K051212" TO "K080238".

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED: "INTERMITTENTLY WOULD DISPLAY VALUES AND THEN SUDDENLY DISPLAY NO VALUES WITH NO ERROR MESSAGE" NO CONSEQUENCES OR IMPACT TO PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483959 RAINBOW RC-4 OXIMETER DQA MASIMO - 40 PARKER 2406 16C3X 00843997003193

    Patients

    Seq Age Sex Outcome Treatment
    1