BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMSTAR M-SERIES (DC) HEATED HUMIDIFIER

    MDR report key: 2411208 · Received December 14, 2011

    Report

    Report Number
    2518422-2011-00195
    Event Type
    Malfunction
    Date Received
    December 14, 2011
    Date of Event
    November 1, 2011
    Report Date
    November 14, 2011
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    PMA / PMN Number
    K072996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: HISTORICAL REVIEW OF AFFECTED COMPLAINT RECORDS. 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. FRETTING IS A COMBINATION OF FRICTIONAL WEAR AND CORROSION CAUSED BY SMALL AMPLITUDE MOTION BETWEEN THE MATING MATERIALS OF THE CONNECTOR. THE SOURCE OF THE SMALL AMPLITUDE MOTION WAS ATTRIBUTED TO TEMPERATURE CYCLING BETWEEN THE MATING METALS DUE TO ELECTRICAL CURRENT, PULSED TO THE HEATER LOAD. CORROSION GENERATED ON THE TERMINAL CONTACTS DUE TO FRETTING RESULTED IN INCREASED RESISTANCE WITHIN THE CONNECTOR CAUSING INCREASED HEAT. THE INSUFFICIENT SPRING FORCE ESTABLISHED BY THE FEMALE TERMINAL CONTACTS WITHIN THE HEATER PLATE WIRE-HARNESS IS ATTRIBUTABLE TO THE GEOMETRY OF THE TERMINAL CONTACTS DEVELOPED DURING THE SUPPLIER'S MANUFACTURING PROCESS. THE INTERMITTENT CONNECTION CAN POTENTIALLY CAUSE AN INCREASE IN HEAT DUE TO ELECTRICAL ARCING. THE HEATER PLATE WIRE-HARNESS CONNECTOR HAD BEEN PURCHASED FROM TWO SEPARATE SUPPLIERS. BASED ON AN ANALYSIS OF THE MANUFACTURER'S COMPLAINT DATABASE AND EVALUATION OF THE UNITS RETURNED, THE MANUFACTURER DETERMINED THAT THE FAILURE MODE WAS ISOLATED TO A SINGLE SUPPLIER. THE COMPOSITION OF THE METAL TERMINAL CONTACTS WITHIN ONE SUPPLIER'S CONNECTOR PROVED TO BE SUSCEPTIBLE TO FRETTING AND THE GEOMETRY OF THE CONDUCTORS FROM THE SAME SUPPLIER'S CONNECTOR INCREASED THE POTENTIAL FOR AN INTERMITTENT CONNECTION TO OCCUR. CONNECTORS PURCHASED FROM THE OTHER SUPPLIER DID NOT HAVE THE SAME CHARACTERISTICS IN GEOMETRY OR THE COMPOSITION OF METAL TERMINAL CONTACTS. THE MANUFACTURER WAS ABLE TO ISOLATE THE POPULATION OF DEVICES POTENTIALLY MANUFACTURED WITH THE SPECIFIC SUPPLIER'S SUSPECT CONNECTOR AND ISSUED A VOLUNTARY FIELD CORRECTIVE ACTION. (B)(4).

    Description of Event or Problem · 1

    A SLEEP CENTER REPORTED TO THE MANUFACTURER THAT A PATIENT WAS AWAKENED BY A MELTING PLASTIC / BURNING ODOR AND THAT THE PATIENT SAW THERMAL DAMAGE TO THE BOTTOM ENCLOSURE OF THE HUMIDIFIER. THERE WAS NO REPORT OF INJURY OR HARM. THE DEVICE WAS EXAMINED BY THE MANUFACTURER AND THE COMPLAINT OF THE HEATED HUMIDIFIER HAVING BEEN THERMALLY DAMAGED WAS CONFIRMED. A THERMAL VOID WAS FOUND IN BOTH 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 ASSOCIATED CONTINUOUS POSITIVE AIRWAY PRESSURE DEVICE (CPAP) WAS ALSO EVALUATED BY THE MANUFACTURER. WHILE THERE WAS EVIDENCE OF THERMAL DEFORMATION TO THE BOTTOM ENCLOSURE, PROXIMAL TO THE THERMAL DAMAGE OF THE HUMIDIFIER, THE ENCLOSURE WAS NOT COMPROMISED. THERE WAS NO EVIDENCE OF FAILURE OF THE CPAP. THERE WAS NO EVIDENCE OF THERMAL COMPONENT FAILURE OR COMPROMISE OF THE AIRWAY. IT IS , THEREFORE, LISTED AS A CONCOMITANT DEVICE. THE MANUFACTURER 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.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR (B)(4)| REMSTAR M-SERIES: 100M