BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M-SERIES (DC) HEATED HUMIDIFIER

    MDR report key: 2177220 · Received July 6, 2011

    Report

    Report Number
    2518422-2011-00075
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 7, 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
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. (CONTINUED ON MFR # 251842-2011-00061, P. 3 OF 3). 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. 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 N HEAT DUE TO ELECTRICAL ARCING. THE HEATER PLATE WIRE-HARNESS CONNECTOR HAD BEEN PURCHASED FROM TWO SEPARATE SUPPLIERS. BASED ON AN ANALYSIS OF THE MFR'S COMPLAINT DATABASE AND EVAL OF THE UNITS RETURNED, THE MFR 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 MFR WAS ABLE TO ISOLATE THE POPULATION OF DEVICES POTENTIALLY MANUFACTURED 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 A PHILIPS RESPIRONICS HEATED HUMIDIFIER AND AN ASSOCIATED CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE HAD MELTED TOGETHER. THE PT ALLEGED THAT THE DEVICE HAD CAUGHT ON FIRE BUT REPORTED THAT THERE WERE NO FLAMES OBSERVED. THERE WAS NO REPORT OF INJURY OR HARM. THE DEVICE WAS EXAMINED BY THE MFR AND THE COMPLAINT THE HEATED HUMIDIFIER HAD EMITTED SMOKE AND MELTED TO IS ASSOCIATED BASE UNIT 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 ENCLOSURE OF THE ASSOCIATED CPAP WAS NOT COMPROMISED AND CPAP FUNCTION WAS UNAFFECTED.

    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 55 YR REMSTAR M-SERIES: 100M, (B)(4)