BEUDAMED
    FDA Adverse Event Other Summary report: N

    NONE

    MDR report key: 2681269 · Received July 12, 2012

    Report

    Report Number
    2921601-2012-00009
    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 A INFANT. THE INFANT REPORTEDLY HAD ITS HEART RATE MONITOR ALARM AND WAS OBSERVE TO HAVE A "PROFOUND BRADYCARDIA AND DESATURATION." REPORTEDLY, THERE WAS A DISCONNECTION AT THE "JOINT BETWEEN THE NASAL CANNULA AND THE OXYGEN DELIVERING TUBING." SALTER LABS CONTACTED THE INITIAL COMPLAINANT SEVERAL TIMES TO DETERMINE HOW THE PATIENT WAS DOING AND WHETHER THE PRODUCT 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 IMPOSSIBLE 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