BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLABY 3 PHOTO THERAPY UNIT

    MDR report key: 1032563 · Received March 27, 2008

    Report

    Report Number
    1032563
    Event Type
    Malfunction
    Date Received
    March 27, 2008
    Date of Event
    March 10, 2008
    Report Date
    March 27, 2008
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    LBI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PARENTS REPORT THAT THEY WERE AWAKENED BY A SHATTERING NOISE, "A HUGE BANG" "LIKE A WINDOW SHATTERING." THE PARENTS WENT TO THE ROOM WHERE THEIR INFANTS WERE AND OBSERVED GLASS ON THE FLOOR (THE INFANTS WERE RECEIVING PHOTOTHERAPY). THE YELLOW LIGHT ON WALLABY UNIT WAS FLASHING AND THE GREEN LIGHT WAS ON. THE UNIT APPEARED TO BE OPERATING CORRECTLY AND THE SECOND BULB HAD TURNED ON AUTOMATICALLY AND PHOTOTHERAPY WAS BEING DELIVERED. THE PARENTS REPORTED UNPLUGGING THE UNIT AND CLEANING UP THE GLASS. NO REPORT OF INJURY. THE UNIT WAS PLUGGED BACK IN TO CONTINUE THERAPY. THE PARENTS CALLED THE HOSPITAL TO PROVIDE NOTIFICATION OF THE EVENT. THE HOME WAS VISITED BY A STAFF MEMBER. THE INVOLVED WALLABY UNIT WAS RECOVERED AND RETURNED TO THE MANUFACTURER FOR EVALUATION.MANUFACTURER RESPONSE FOR PHOTOTHERAPY, SYSTEM, INFANT, WALLABY 3 PHOTO THERAPY UNIT: PER A REPORT FORWARDED FROM THE COMPANY - UNABLE TO CONFIRM COMPLAINT OF "BULB EXPLODED." THERE IS NO EVIDENCE, SHARDS, OR PARTS INTERNAL OF UNIT. HOWEVER THERE IS A BULB ENCLOSURE INSTALLED WITH A MISSING ELEMENT. UNIT ALSO APPEARS TO HAVE BEEN DROPPED. THE FRONT PANEL ENCLOSURE IS CRACKED/MARRED/DAMAGED. THE OUTER METAL ENCLOSURE IS DENTED ON THE LEFT REAR CORNER. REPLACED BULBS WITH KNOWN GOOD BULBS AND RAN FOR 24 HOURS TOTAL (SWITCHING BOTH). NO OPERATIONAL ISSUES WERE FOUND/NOTED. QA WILL HANG ONTO AND ARCHIVE THE SUSPECT BULB FOR A PERIOD OF ONE YEAR. UNIT IS SERVICEABLE AND WILL BE RETURNED IN SERVICE FOR REPAIR AFTER INVESTIGATION COMPLETED AND UNIT RELEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLABY 3 PHOTO THERAPY UNIT PHOTOTHERAPY SYSTEM, INFANT LBI RESPIRONICS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 5 DA