BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M-SERIES (DC) HEATED HUMIDIFIER

    MDR report key: 2153204 · Received June 17, 2011

    Report

    Report Number
    2518422-2011-00061
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 19, 2011
    Manufacturer
    RESPIRONICS INC.
    Product Code
    BZD
    PMA / PMN Number
    K072996
    Removal / Correction Number
    Z-1260-2009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EXAMINED BY THE MFR AND THE COMPLAINT THAT THE HEATED HUMIDIFIER HAD EMITTED SMOKE AND AN ELECTRICAL BURNING ODOR WAS CONFIRMED. A THERMAL VOID WAS FOUND IN THE DEVICE'S TOP AND BOTTOM ENCLOSURES. THE DAMAGE TO THE ENCLOSURES WAS PROXIMAL TO A THERMALLY DAMAGED PORTION OF THE DEVICE'S PRINTED CIRCUIT ASSEMBLY (PCA), IN THE LOCATION OF THE J3 CONNECTOR TO THE HUMIDIFIER HEATER-PLATE. THE ENCLOSURE OF THE ASSOCIATED CPAP WAS NOT COMPROMISED AND CPAP FUNCTION WAS UNAFFECTED. THE MFR COMPLETED THE INVESTIGATION OF THE FAILURE MODE OF THE J3 CONNECTOR AND CONCLUDED IT IS CAUSED BY HIGH RESISTANCE HEATING BETWEEN THE HEATER-PLATE CONNECTOR AND THE HEATER-PLATE WIRE HARNESS. ENGINEERING DETERMINED THAT THE HIGH RESISTANCE HEATING WAS ATTRIBUTABLE TO CORROSION OF THE CONNECTOR'S CONTACT TERMINALS DUE TO FRETTING AND/OR INTERMITTENT ELECTRICAL CONNECTION CAUSED BY INSUFFICIENT SPRING FORCES ON THE WIRE-HARNESS. METHODS - HISTORICAL REVIEW OF AFFECTED COMPLAINT RECORDS: FRETTING IS A COMBINATION OF FRICTIONAL WEAR AND CORROSION CAUSED BY SMALL AMPLITUDE MOTION BETWEEN THE MATING MATERIALS OF THE CONNECTOR. (B)(4). THE MFR WAS ABLE TO ISOLATE THE POPULATION OF DEVICES POTENTIALLY MFG WITH THE SPECIFIC SUPPLIER'S SUSPECT CONNECTOR AND ISSUED A VOLUNTARY FIELD CORRECTIVE ACTION. THE FDA WAS NOTIFIED IN JULY 2009 AND PHILIPS RESPIRONICS WAS ISSUED RECALL NUMBER Z-1260-2009.

    Description of Event or Problem · 1

    A DURABLE MEDICAL EQUIPMENT SUPPLIER (DME) REPORTED THAT THE HEATED HUMIDIFIER HAD EMITTED SMOKE AND AN ELECTRICAL BURNING ODOR. THERE WAS NO REPORT OF INJURY OR HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M-SERIES (DC) HEATED HUMIDIFIER CPAP SYSTEM BZD RESPIRONICS INC. 1051158

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR REMSTAR M-SERIES, 100M, (B)(4)