BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BABY CONTROLLED WALL MOUNT INFANT WARMER

    MDR report key: 1900809 · Received November 16, 2010

    Report

    Report Number
    9611451-2010-00695
    Event Type
    Malfunction
    Date Received
    November 16, 2010
    Report Date
    October 18, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    FMT
    PMA / PMN Number
    K971461
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WE ARE CURRENTLY ENDEAVOURING TO OBTAIN MORE INFORMATION WITH REGARD TO THE COMPLAINT DEVICE. WE WILL PROVIDE A FOLLOW-UP REPORT UPON RECEIPT OF THE DEVICE AND COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE RETURNED COMPLAINT DEVICE WAS VISUALLY INSPECTED. PHOTOGRAPHS WERE ALSO PROVIDED FOR EVALUATION. RESULTS: THE VISUAL INSPECTION REVEALED THE SCREW BOSS ON THE FRONT END OF THE UPPERCASE WAS BROKEN INTO TWO PARTS AND A CRACK WAS OBSERVED FROM THE BOSS BASE AND SUPPORTING RIBS. THE PHOTOGRAPH SHOWED THE BROKEN PARTS TO BE GLUED TOGETHER. A HAIRLINE CRACK WAS OBSERVED ON THE LOWER CASE ON THE SCREW HOLE OF THE LIGHT BOX. A PHOTOGRAPH OF THE CHIPPED CERAMIC INSULATOR WAS PROVIDED, HOWEVER THIS WAS NOT RETURNED FOR INSPECTION. A LOT CHECK REVEALED NO OTHER SIMILAR COMPLAINTS FOR THIS LOT NUMBER. CONCLUSION: THE MOBILE INFANT WARMER IS SUSCEPTIBLE TO IMPACT DAMAGE PARTICULARLY IF IT IS TRANSPORTED FROM ONE ROOM TO ANOTHER OR IF THE HEAD IS SWIVELED. THE LIKELY CAUSE OF THE DAMAGE TO THE UPPER CASE OF THE COMPLAINT DEVICE IS ACCIDENTAL IMPACT DAMAGE. THE HOSPITAL REPORTED THAT THE WALL MOUNT WARMER HEAD WAS USED NEXT TO A WALL CABINET THAT IT CAME IN CLOSE CONTACT WITH, THEREFORE AS THE WARMER HEAD CAN BE SWIVELLED, IT IS POSSIBLE FOR IT TO BE DAMAGED THROUGH COLLISION WITH THE WALL. THE CERAMIC INSULATOR IS MADE OF SILICEOUS PORCELAIN WHICH IS BRITTLE AND ALSO SUSCEPTIBLE TO IMPACT DAMAGE. THE CRACKED SCREW BOSS IS LIKELY TO BE RELATED TO ACCIDENTAL IMPACT DAMAGE OR DAMAGE CAUSED BY THE INCORRECT REMOVAL OF THE WARMER HEAD CASE.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(4) REPORTED THAT THE CASING OF AN IW980 BABY CONTROLLED WALL MOUNT INFANT WARMER WAS "CRACKED AT THE RETAINER THAT HOLDS THE SCREW IN." THE CUSTOMER FURTHER REPORTED THAT THE SCREW WAS "LOOSE AND LOOKS LIKE IT BROKE OFF." NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT THE CASING OF AN IW980 BABY CONTROLLED WALL MOUNT INFANT WARMER WAS "CRACKED AT THE RETAINER THAT HOLDS THE SCREW IN". THE CUSTOMER FURTHER REPORTED THAT THE SCREW WAS "LOOSE AND LOOKS LIKE IT BROKE OFF". THE CUSTOMER FURTHER REPORTED THAT THE WALL MOUNT INFANT WARMER HEAD WAS USED NEXT TO A WALL CABINET AND HAD COME IN CLOSE CONTACT WITH IT. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BABY CONTROLLED WALL MOUNT INFANT WARMER FMT FMT FISHER & PAYKEL HEALTHCARE LTD IW980

    Patients

    Seq Age Sex Outcome Treatment
    1