BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMSTAR M SERIES POWER SUPPLY

    MDR report key: 1374582 · Received April 16, 2009

    Report

    Report Number
    2518422-2009-00018
    Event Type
    Malfunction
    Date Received
    April 16, 2009
    Date of Event
    March 1, 2009
    Report Date
    March 17, 2009
    Manufacturer
    RESPIRONICS INC
    Product Code
    BZD
    PMA / PMN Number
    K052110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL OF THE EXTERNAL POWER SUPPLY REVEALED FUSING OF ITS DETACHABLE POWER CORD AND AC INLET CONNECTOR. A THERMAL VOID, APPROX. 2MM X 2MM, WAS ALSO FOUND IN THE LOWER HALF OF THE POWER SUPPLY'S HOUSING. THE MFR HAS RETURNED THE POWER SUPPLY ASSEMBLY TO ITS SUPPLIER FOR FURTHER INVESTIGATION OF ITS FAILURE. THE CPAP WAS EVALUATED USING POST-SERVICE TEST PROCEDURES AND WAS FOUND TO OPERATE AS DESIGNED, PASSING ALL TESTS PERFORMED. BASED ON THESE TEST RESULTS, THE MFR CONCLUDES THAT THE CPAP DEVICE (REF. CONCOMITANT MEDICAL PRODUCTS) WAS NOT A CAUSE OR CONTRIBUTING FACTOR IN THE POWER SUPPLY ASSEMBLY FAILURE. THE MFR WILL FILE A F/U REPORT WHEN THEIR INVESTIGATION OF THE EXTERNAL POWER SUPPLY ASSEMBLY FAILURE IS COMPLETE.

    Description of Event or Problem · 1

    A DURABLE MEDICAL EQUIPMENT SUPPLIER (DME) REPORTED THE FAILURE OF A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE TO THE MFR. THE FAILURE REPORTEDLY OCCURRED DURING PT USE OF THE PRODUCT AND WAS ASSOCIATED WITH A BURNING ODOR. THERMAL DAMAGE TO THE LOWER HOUSING OF THE CPAP DEVICE'S EXTERNAL POWER SUPPLY WAS ALSO REPORTED. NO HARM OR INJURY WAS ALLEGED. THE MFR RECEIVED THE CPAP DEVICE AND ITS EXTERNAL POWER SUPPLY ASSEMBLY FROM THE DME FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REMSTAR M SERIES POWER SUPPLY EXTERNAL POWER SUPPLY (CPAP SYSTEM) BZD RESPIRONICS INC 1015642

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR PRESSURE DEVICE), (B)(4)| REMSTAR M SERIES (CONTINOUS POSITIVE AIRWAY