BEUDAMED
    FDA Adverse Event Death Summary report: N

    BRIGHT EMBRACE MODEL SBL60

    MDR report key: 3347299 · Received September 5, 2013

    Report

    Report Number
    2183604-2013-00001
    Event Type
    Death
    Date Received
    September 5, 2013
    Report Date
    September 3, 2013
    Manufacturer
    PHYSICIAN ENGINEERED PRODUCTS, INC.
    Product Code
    LBI
    PMA / PMN Number
    K110550
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME PEP HAS NO INDICATION THAT THE DEVICE MALFUNCTIONED. WE ARE ATTEMPTING TO HAVE IT SENT FROM (B)(6) FOR TESTING. IT APPEARS THERE WERE, PERHAPS, SEVERAL DEVIATIONS FROM THE INSTRUCTIONS THAT ACCOMPANIED THE DEVICE - IN (B)(6): THE ENVIRONMENTAL ROOM TEMPERATURE LIMITS WERE NOT OBSERVED; POOR STAFF MONITORING OF BABY'S TEMPERATURE AND CONDITION; POSSIBLE FAILURE TO REMOVE BABY FROM THE DEVICE FOR 10 MINUTES OF EVERY HOUR. PEP HAS PLACED ALL BRIGHT EMBRACE SALES ON HOLD UNTIL A COMPLETE REVIEW IS COMPLETED; A RECALL OF THE FEW SALES THAT HAVE OCCURRED IS BEING CONTEMPLATED.

    Description of Event or Problem · 1

    IN (B)(6) 2013, PHYSICIAN ENGINEERED PRODUCTS (PEP) DONATED 9 BRIGHT EMBRACE NEWBORN PHOTOTHERAPY DEVICES TO PRIMARY CONTACT: DR (B)(6). DR (B)(6) CONTACT INFO (HIS HOURS FOR ANSWERING EMAILS, PHONE CALLS ARE 9 AM TIL 3 PM EAST COAST TIME). LOCATION: HOSPITAL ADDRESS: (B)(6). ATTENTION: DR (B)(6). TODAY, SADLY, PEP REC'D AN EMAIL FROM DR (B)(6) INDICATING THAT: "WE HAD A PROBLEM ONE OF THE CHILDREN WHO USED ONE SUFFERED THIRD-DEGREE BURNS AND DIED; WE THINK THAT THE CONDITION OF THE ENVIRONMENT, AS IT IS VERY HOT ALONG WITH THE ADD'L TEMPERATURE PUT OUT BY THE BRIGHT (SIC) IS TOO HIGH T 41 GRADO CELSIUS (ABOUT 106 DEGREES FAHRENHEIT.) "I THINK TO CONTINUE USING THE DEVICE WE WOULD NEED AN ENVIRONMENTALLY CONTROLLED AREA TO DECREASE THE TEMPERATURE, FOR THIS SITUATION WE STOPPED USING THEM AND HOSPITAL AUTHORITIES CURRENTLY RECOMMENDED NOT TO USE THE DEVICES. "WE ALSO BELIEVE THERE WAS NO GOOD MONITORING BY STAFF AT TIME TO BE THE BABY WITH BRIGHT EMBRACE AS WE ALREADY HAD 5 OTHER CHILDREN USE THE DEVICE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441184 BRIGHT EMBRACE MODEL SBL60 BRIGHT EMBRACE LBI PHYSICIAN ENGINEERED PRODUCTS, INC. SBL60 120801A

    Patients

    Seq Age Sex Outcome Treatment
    1 FEW DAY Death