BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CPAP MACHINE

    MDR report key: 2093781 · Received May 12, 2011

    Report

    Report Number
    MW5020589
    Event Type
    Injury
    Date Received
    May 12, 2011
    Date of Event
    April 22, 2011
    Report Date
    May 12, 2011
    Product Code
    BZD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT HOSPITALIZED ON (B)(6) 2011, WITH HYPERCARBIA AFTER USE OF CPAP MACHINE. DURING NURSING VISIT ON (B)(6) 2011, NURSE CALLED (B)(6) TO REQUEST URGENT VISIT BY TECHNICIAN TO CHECK EQUIPMENT. PER PT REPORT, TECH CAME TO HOUSE AND SAID CPAP MACHINE WAS DEFECTIVE AND REPLACED EQUIPMENT. UNABLE TO ASCERTAIN MFR OF CPAP MACHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CPAP MACHINE NONE BZD

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization