BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMSTAR HEATED HUMIDIFIER

    MDR report key: 1003422 · Received February 21, 2008

    Report

    Report Number
    2518422-2008-00006
    Event Type
    Malfunction
    Date Received
    February 21, 2008
    Date of Event
    January 22, 2008
    Report Date
    January 22, 2008
    Manufacturer
    RESPIRONICS INC.
    Product Code
    BTT
    PMA / PMN Number
    K012633
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL ASSISTANT

    Narratives

    Description of Event or Problem · 1

    A DURABLE MEDICAL EQUIPMENT COMPANY REPORTED A PRODUCT USER ALLEGED THEIR REMSTAR HEATED HUMIDIFIER HAD MALFUNCTIONED. THE MALFUNCTION RESULTED IN THERMAL DAMAGE TO THE ENCLOSURE OF THE HUMIDIFIER. THE DEVICE WAS IN USE AT THE TIME OF THE EVENT. THERE WAS NO REPORTED PT HARM OR INJURY. THE MFR'S ENGINEERING DEPT INVESTIGATED THE DEVICE AND DETERMINED THAT THE COMBINATION OF WATER AND FOREIGN MATERIAL INGRESS LED TO THE FAILURE OF THE PCA BOARD IN THE HUMIDIFIER. THIS RESULTED IN THE THERMAL DAMAGE TO THE HOUSING OF THE DEVICE. A THIRD PARTY WAS COMMISSIONED BY THE MFR TO INVESTIGATE THE ISSUE AND IDENTIFIED THE FOREIGN MATERIAL AS WOOD AND CHARACTERIZED THE CONTAMINANT FOUND INSIDE THE ENCLOSURE IS CONSISTENT WITH TAP WATER RESIDUE. HOWEVER, THE THIRD PARTY AND THE MFR ARE UNABLE TO DETERMINE HOW THE FOREIGN MATERIAL ENTERED THE ENCLOSURE. UPON COMPLETION OF THE INVESTIGATION, THE MFR HAS CONCLUDED THAT THE EVENT AND FINDINGS ARE CONSISTENT WITH DEVICE CARE AND HANDLING IN A MANNER CONTRARY TO PRODUCT LABELING. THIS CARE AND HANDLING RESULTED IN TAP WATER AND FOREIGN MATERIAL INGRESS OF THE DEVICE. THE MFR USER MANUAL LABELING CAUTIONS USERS TO DRAIN AND DRY FLUIDS SPILLED ONTO THE UNIT PRIOR TO USING THE DEVICE AND THE FINDINGS INDICATE THAT THIS DID NOT OCCUR. BASED ON CONTINUAL MONITORING OF COMPLAINT DATA FOR THE AFFECTED DEVICE THE MFR HAS CONCLUDED THAT PROBABILITY OF A SIMILAR EVENT OCCURRING IS REMOTE, GIVEN THE DEVICE IS HANDLED AND USED ACCORDING TO PRODUCT CARE AND HANDLING LABELING. THE MFR, THEREFORE, HAS CONCLUDED THAT CORRECTIVE, PREVENTATIVE AND REMEDIAL ACTIONS ARE NOT INDICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REMSTAR HEATED HUMIDIFIER HUMIDIFIER, RESPIRATORY GAS ( DIRECT PATIENT INTERFACE) BTT RESPIRONICS INC. 1005792

    Patients

    Seq Age Sex Outcome Treatment
    1