BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    USPO2 SET OXIMETRY CABLE

    MDR report key: 4531880 · Received January 8, 2015

    Report

    Report Number
    2031172-2015-00012
    Event Type
    Malfunction
    Date Received
    January 8, 2015
    Date of Event
    December 2, 2014
    Report Date
    December 9, 2014
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K121914
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED TO MASIMO FOR EVAL. WHEN THE INVESTIGATION IS COMPLETE A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR # WAS 2031172-2014-00012. HOWEVER, THE CORRECT MDR # SHOULD BE 2031172-2015-00012.

    Additional Manufacturer Narrative · 1

    THE RETURNED CABLE WAS EVALUATED. DURING INVESTIGATION, THE MESSAGE, "BOARD IS NOT RESPONDING DURING PROTOCOL DETECTION" WAS DISPLAYED. THE ERROR MESSAGE DISPLAYED RENDERS THE DEVICE NON-FUNCTIONAL. A SERVICE HISTORY RECORD REVIEW REVEALS THAT THIS UNIT WAS IN THE FIELD FOR OVER NINE (9) MONTHS WITH NO PREVIOUS REPORTED ISSUES PRIOR TO THIS REPORTED EVENT. UPDATED ANSWER TO INITIAL REPORTER ALSO SENT REPORT TO FDA TO "NO".

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CABLE WAS READING LOW SPO2 WHILE ON A PT. SPO2 WAS VERIFIED AS "NORMAL" WITH THE PHILIPS VS3 WITH FAST. THE USPO2 READING WAS IN THE "40'S" WHEN ACTUAL SAT WAS IN THE "UPPER 90'S". THERE WAS NO CONSEQUENCE OR IMPACT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15058 USPO2 SET OXIMETRY CABLE OXIMETER DQA MASIMO CORPORATION 3577 V31045

    Patients

    Seq Age Sex Outcome Treatment
    1