BEUDAMED
    FDA Adverse Event Other Summary report: N

    NONE

    MDR report key: 2681248 · Received July 12, 2012

    Report

    Report Number
    2921601-2012-00008
    Event Type
    Other
    Date Received
    July 12, 2012
    Date of Event
    June 13, 2012
    Report Date
    July 11, 2012
    Product Code
    CAT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(4) 2012, SALTER LABS RECEIVED A NOTIFICATION FROM (B)(6) REGARDING AN INCIDENT THAT WAS REPORTED FROM A HOSPITAL WHERE A CANNULA DISCONNECTED WHILE ON AN INFANT. THE INFANT REPORTEDLY HAD ITS HEART RATE MONITOR ALARM SOUND AND WAS OBSERVED TO HAVE OXYGEN LEVEL OF 42%. REPORTEDLY, THERE WAS A DISCONNECTION AT THE "NASAL PRONG COMPONENT." SALTER LABS CONTACTED THE INITIAL COMPLAINANT SEVERAL TIMES TO DETERMINE HOW THE PATIENT WAS DOING AND WHETHER THE PRODUCT WAS AVAILABLE FOR RETURN. THE INITIAL COMPLAINANT RESPONDED STATING THE PATIENT "EXPERIENCED A BRIEF HYPOXIC EVENT IDENTIFIED BY A DROP IN OXYGEN SATURATION THAT WAS TREATED IMMEDIATELY WITH A GOOD RESPONSE AND NO OBVIOUS LONG TERM EFFECT" AND REPORTED THE UNIT IN QUESTION WAS AVAILABLE FOR RETURN TO SALTER LABS. HOWEVER, THE UNITS WERE NOT RECEIVED BY SALTER LABS. FURTHER ATTEMPTS AT CONTACT REGARDING THE RETURN OF THE UNIT HAVE NOT BEEN SUCCESSFUL. WITHOUT THE UNITS IN QUESTION AVAILABLE FOR ANALYSIS IT IS NOT POSSIBLE TO CONFIRM THE COMPLAINT OR DETERMINE A ROOT CAUSE. THIS IS A FINAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE CAT

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other