BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SULLIVAN V

    MDR report key: 518095 · Received March 24, 2004

    Report

    Report Number
    8020057-2004-00002
    Event Type
    Injury
    Date Received
    March 24, 2004
    Date of Event
    June 26, 2003
    Report Date
    March 24, 2004
    Manufacturer
    RESMED LTD.
    Product Code
    BZD
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PT WAS TOTALLY DEAF WHILE USING THE CPAP DEVICE. THE PT LOST THEIR HEARING IN 2003 BUT PT DID NOT REPORT THE INCIDENT TO THE CO UNTIL EIGHT MOS LATER. THE SETTING SHOULD BE 18 CM H2O NOT 18 PSI AS CLAIMED BY THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SULLIVAN V CPAP DEVICE BZD RESMED LTD. 21001 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Disability