BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LNOP RED PC-04

    MDR report key: 3973125 · Received June 5, 2014

    Report

    Report Number
    2031172-2014-00067
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    April 28, 2014
    Report Date
    May 6, 2014
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K040214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS FOR PRODUCT RETURN AND ADD'L INFO REQUESTS WERE MADE. PER THE CUSTOMER'S REQUEST NEW CABLES WERE PROVIDED TO THE CUSTOMER; HOWEVER, THE DEVICE WAS NOT MADE AVAILABLE TO MASIMO TO ALLOW AND ANALYSIS TO BE PERFORMED. IF AND WHEN INFO BECOMES AVAILABLE OR ONCE THE UNIT IS RETURNED AND AN EVAL IS PERFORMED, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO RAD-5V UNITS WERE USED ON A NEWLY BORN INFANT AND GAVE READINGS OF 0-4% SPO2 READINGS AND HEART RATE 25 BPM. READINGS WERE TAKEN IN A HOSP ROOM SETTING, POST LABOUR AND AFTER DELIVERY. A SPACELABS MONITOR WAS ALSO USED ON THE INFANT AND GAVE VALUES WITHIN EXPECTATIONS. THE CUSTOMER CONFIRMED THAT THE SPACELABS READINGS WERE WITHIN THE ACCEPTABLE RANGE FOR NEWBORNS, HOWEVER, THE CUSTOMER COULD NOT PROVIDE WHAT THE EXPECTED RANGE IS OR WHAT THE SPACELABS READINGS WERE. THE CUSTOMER CANNOT CONFIRM IF THE RAD-5VS WERE USED ON THE PT BEFORE OR AFTER APPLICATION OF SPACELABS MONITOR. THE MODEL # OF SPACELABS UNIT OR OTHER UNIT IDENTIFICATION WAS ALSO NOT PROVIDED. A PT CABLE PN-2058 WAS USED ON EACH RAD-5V WHEN USED ON THE PT. EACH RAD-5V HAD AN ADHESIVE SENSOR USED ON THE PT BUT THE SENSOR INFO WAS NOT AVAILABLE. THE CUSTOMER CONFIRMS THAT THEY CANNOT RETURN THE ITEMS. NO PT INJURY WAS REPORTED NO MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328623 LNOP RED PC-04 DQA MASIMO CORPORATION LNOP RED PC-04 9N183

    Patients

    Seq Age Sex Outcome Treatment
    1