BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLABY 3 PHOTOTHERAPY SYSTEM

    MDR report key: 3116442 · Received March 8, 2013

    Report

    Report Number
    3007056120-2013-00002
    Event Type
    Malfunction
    Date Received
    March 8, 2013
    Date of Event
    February 28, 2013
    Report Date
    February 28, 2013
    Manufacturer
    CHILDRENS MEDICAL VENTURES
    Product Code
    LBI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS INVESTIGATION IS FOCUSED ON THE SECOND DEVICE ASSOCIATED WITH THE LOW LIGHT OUTPUT RESULTING IN A DELAY OF PHOTO THERAPY. THE BIOMED TECHNICIAN STATED THAT THE EXACT DEVICE ASSOCIATED WITH THE REPORTED INCIDENT COULD NOT BE IDENTIFIED. THE BIO MED TECHNICIAN ALSO EXPLAINED THAT ALL THE REPAIRS FOR THE WALLABY UNITS ARE DONE IN HOUSE AND THAT THE DEVICE WOULD NOT BE RETURNED FOR EVALUATION. THE BIOMED'S INVESTIGATION REPORTED THAT THE LIGHT OUTPUT OF THE WALLABY WAS MEASURED USING A JOEY DOSIMETER. THE JOEY DOSIMETERS USED TO MEASURE THE LIGHT RADIANCE OF THE WALLABY DEVICE WAS REPORTEDLY LAST CALIBRATED IN 2010. THE JOEY DOSIMETER REQUIRES AN ANNUAL CALIBRATION TO ENSURE PROPER FUNCTIONALITY. THE WALLABY 3 PHOTOTHERAPY SYSTEM PROVIDES A PHOTOTHERAPY LIGHT SOURCE FOR USE IN THE HOME ENVIRONMENT FOR THE TREATMENT OF HYPERBILIRUBINEMIA. THE DEVICE DOES DELIVER ENERGY IN THE FORM OF VISIBLE LIGHT; AROUND 400-550MM WAVELENGTH. A PROLONGED OR DECREASE TREATMENT SESSION WOULD NOT BE LIFE THREATENING TO THE PATIENT. THE USE OF THIS DEVICE REQUIRES A PRESCRIPTION BY A LICENSED PHYSICIAN AND A PERIODIC CHECK OF THE BABY'S BLOOD IS REQUIRED TO ENSURE PROPER THERAPY. THEREFORE, THE DEVICE HAS BEEN CLASSIFIED AS A MINOR LEVEL OF CONCERN DEVICE. THE WALLABY 3 PHOTOTHERAPY SYSTEM WAS DISCONTINUED (B)(6) 2008. SERVICE REQUESTS, PART SUPPORT AND ALL WARRANTY OBLIGATIONS WERE HONORED UNTIL (B)(6) 2011. IT IS DETERMINED THAT THE COMPLAINT ISSUE ALLEGED BY THE CUSTOMER WAS NOT ABLE TO BE CONFIRMED BECAUSE THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. ALTHOUGH THE ALLEGED EVENT COULD NOT BE SUBSTANTIATED, NO RESULTING EFFECT ON A PATIENT OR POTENTIAL USER HAS BEEN REPORTED. IT IS FURTHER DETERMINED THAT IF THE REPORTED ISSUE WAS TO OCCUR, THAT IT MAY HAVE CAUSED OR CONTRIBUTED TO A FAILURE OF THE DEVICE TO PERFORM ITS INTENDED USE, OR RESULTED IN CUSTOMER DISSATISFACTION WITH THE PERFORMANCE OF THE PRODUCT, BUT WOULD NOT PRESENT AN INCREASED RISK TO PATIENT SAFETY. QUALITY ASSURANCE HAS CONCLUDED THAT NO FURTHER INVESTIGATION ACTIVITY INTO THE ALLEGED EVENT WILL OCCUR.

    Description of Event or Problem · 1

    CHILDREN'S MEDICAL VENTURES (CHMV) RECEIVED MEDWATCH REPORT (B)(4) ON (B)(6) 2013 STATING THAT A BILI BLANKET FOR PHOTO THERAPY TURNED ON AND OFF AUTOMATICALLY. THE DEVICE WAS BEING USED VERTICAL ON VENT SIDE. THAT DEVICE WAS REPLACED WITH A NEW ONE OF THE SAME MODEL. THE SECOND DEVICE WAS PLACED HORIZONTALLY WITH THE VENTS ON THE SIDE OF MACHINE OPEN TO AIR. IT WAS DETERMINED THAT THE LEVEL OF LIGHT RADIANCE OF THE SECOND DEVICE WAS BELOW THE ADEQUATE LEVELS PER PROTOCOL. THERE IS NO ALLEGATION OF PATIENT HARM ASSOCIATED WITH THE REPORTED EVENTS. ADDITIONAL CORRESPONDENCE WITH THE REPORTER OF THE MEDWATCH ((B)(6)) CONCLUDED THAT THE DEVICE IN QUESTION WAS IN FACT A WALLABY DEVICE. PART NUMBER (B)(4). THERE WERE TWO SEPARATE UNITS INVOLVED IN THE REPORT. THE EXACT UNITS IN QUESTION ARE UNKNOWN AND NO SERIAL NUMBER IDENTIFIERS ARE AVAILABLE. THE (B)(6) UNDERSTANDS THAT THE FIRST UNIT ISSUE OF TURNING ON AND OFF AUTOMATICALLY WAS CAUSED BY BLOCKING THE AIR VENT. THE DEVICE SHUTTING OFF IS NOT A MALFUNCTION, BUT AN INCORPORATED DESIGN FEATURE TO PREVENT THE UNIT FROM OVERHEATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100613 WALLABY 3 PHOTOTHERAPY SYSTEM NEONATAL PHOTOTHERAPY UNIT LBI CHILDRENS MEDICAL VENTURES H3600

    Patients

    Seq Age Sex Outcome Treatment
    1