BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESMED S9 AUTOSET

    MDR report key: 6063138 · Received October 28, 2016

    Report

    Report Number
    6063138
    Event Type
    Malfunction
    Date Received
    October 28, 2016
    Date of Event
    October 6, 2016
    Report Date
    October 27, 2016
    Manufacturer
    RESMED CORPORATION
    Product Code
    BZD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PATIENT BROUGHT A CPAP DEVICE FROM HOME FOR USE IN HIS ROOM. STAFF VERIFIED THAT THIS DEVICE WAS SAFE TO BE USED IN THE FACILITY. THE PATIENT PLUGGED THE CPAP INTO THE WALL OUTLET OF THEIR ROOM WHILE IT WAS IN USE. WHILE SLEEPING, THE PATIENT SUSTAINED A BURN FROM THE POWER CORD WHICH WAS FOUND TO BE IN THE PATIENT'S BED. THE PATIENT'S INJURY WAS A BURN TO THE RIGHT UPPER ARM, ABOUT A QUARTER-SIZED IN DIAMETER, AND IT WAS BUBBLING. THE PATIENT COMPLAINED OF PAIN AND REQUESTED TYLENOL. UPON FURTHER INVESTIGATION, IT WAS NOTED THAT THE POWER CORD HAD BEEN STRETCHED ACROSS THE ROOM TO REACH AN ELECTRICAL OUTLET AND THAT THE PATIENT HAD FALLEN ASLEEP ON THE POWER PACK OF THE CORD, WHICH CAUSED OVERHEATING AND THE INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715341 RESMED S9 AUTOSET VENTILATOR, NON-CONTINUOUS BZD RESMED CORPORATION RESMED S9

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other NO OTHER THERAPIES| THE CPAP MACHINE COMES WITH AN ASSOCIATED HUMIDIFI