BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWIFT LT PILLOW - MED

    MDR report key: 1612773 · Received February 17, 2010

    Report

    Report Number
    3004604967-2010-00011
    Event Type
    Injury
    Date Received
    February 17, 2010
    Date of Event
    January 1, 2010
    Report Date
    February 16, 2010
    Manufacturer
    RESMED LTD.
    Product Code
    BZD
    PMA / PMN Number
    K073638
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MASK WAS NOT RETURNED TO RESMED FOR EVAL. WITH THE INFO AVAILABLE, THE SEIZURE IS NOT BELIEVED TO HAVE BEEN CAUSED BY INTERRUPTED CPAP THERAPY. THIS IS BASED ON THE CLINICAL OPINION OF RESMED'S MEDICAL DIRECTOR AS THERE IS NO DOCUMENTED CAUSAL RELATIONSHIP BETWEEN OSA AND GENERALIZED SEIZURES.

    Description of Event or Problem · 1

    RESMED CORP RECEIVED AN EMAIL FROM A PT CLAIMING THAT POOR QUALITY NASAL PILLOWS CREATED OXYGEN DEPRIVATION WHICH CAUSED HIM TO HAVE A GRAND MAL SEIZURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWIFT LT PILLOW - MED SWIFT LT PILLOW BZD RESMED LTD. 60572

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization