BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LNOP MP12 PATIENT CABLE

    MDR report key: 4785173 · Received May 15, 2015

    Report

    Report Number
    2031172-2015-00796
    Event Type
    Malfunction
    Date Received
    May 15, 2015
    Date of Event
    April 15, 2015
    Report Date
    April 19, 2015
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K050068
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE RETURNED CABLE WAS EVALUATED. DURING EVAL, THE CABLE PASSED ALL VISUAL AND FUNCTIONAL TESTING. THE CABLE WAS DETERMINED TO BE FUNCTIONING AS DESIGNED.

    Additional Manufacturer Narrative · 1

    510(K) NUMBER WAS UPDATED TO K050068.

    Description of Event or Problem · 1

    CUSTOMER REPORTED "DOES NOT WORK WHEN CERTAIN PART OF CABLE IS WIGGLE MP5 MONITOR AND MX800 MONITOR: WHEN A CERTAIN PART OF THE CABLE IS WIGGLED READINGS FLUCTUATES BETWEEN 92 TO 100% AND CANNOT STABILIZE. THERE WERE NO PT INJURIES ASSOCIATED WITH THIS CABLE. THE CABLE WAS TESTED WITH LNOP DCI LOT 15C07 IN THE SHOP. I SWAPPED THIS LNOP MP12 CABLE LOT: 14C59 WITH ANOTHER LNOP MP12 CABLE AND STABILIZED. REPLACEMENT CABLE WORKS FINE." NO KNOWN IMPACT OR CONSEQUENCE TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320040 LNOP MP12 PATIENT CABLE OXIMETER DQA MASIMO CORPORATION 2282 14C59

    Patients

    Seq Age Sex Outcome Treatment
    1