BEUDAMED
    FDA Adverse Event Other Summary report: N

    RED LNC-10 PATIENT CABLE

    MDR report key: 3736322 · Received March 27, 2014

    Report

    Report Number
    2031172-2014-00028
    Event Type
    Other
    Date Received
    March 27, 2014
    Date of Event
    February 26, 2014
    Report Date
    February 27, 2014
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DSA
    PMA / PMN Number
    K111888
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT WAS NOT RETURNED FOR EVALUATION DESPITE MULTIPLE ATTEMPTS. INFO WAS MADE AVAILABLE TO MASIMO INDICATING THAT THE PATIENT IS IN GOOD CONDITION. NO MEDICAL INTERVENTION WAS NECESSARY. THE PATIENT'S PARENTS WERE ABLE TO UNTANGLE THE PATIENT WITHOUT INCIDENT. THE PATIENT CABLE WAS ROUTED OVER THE TOPE OF THE CRIB, NOT THROUGH THE SIDE SLATS. THE DIRECTIONS FOR USE FOR THIS CABLE PROVIDE A WARNING TO "CAREFULLY ROUTE CABLE AND PATIENT CABLE TO REDUCE THE POSSIBILITY OF PATIENT ENTANGLEMENT OR STRANGULATION."

    Description of Event or Problem · 1

    TWO YEAR OLD CHILD WAS FOUND IN CRIB WITH PATIENT CABLE WRAPPED TWICE AROUND THE PATIENT'S NECK. THE PATIENT MONITOR DID NOT ALARM DURING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182643 RED LNC-10 PATIENT CABLE DSA MASIMO CORPORATION 2056 13GCM

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Other