BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLINA

    MDR report key: 820477 · Received February 21, 2007

    Report

    Report Number
    820477
    Event Type
    Injury
    Date Received
    February 21, 2007
    Date of Event
    February 12, 2007
    Report Date
    February 20, 2007
    Manufacturer
    MEDQUIP, INC.
    Product Code
    CAF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    NA ANSWERED RESIDENT CALL LIGHT. RESIDENT HAD BEEN USING THE NEBULIZER. A FAMILY MEMBER HAD SHUT OFF THE NEBULIZER BECAUSE THERE WAS AN ODOR THAT SMELLED LIKE SOMETHING WAS BURNING. NO SMOKE NOTED, THOUGH, THE UNIT WAS NOT. NA UNPLUGGED THE UNIT FROM AN OUTLET STRIP AND CALLED A NURSE. THE NURSE REMOVED THE UNIT FROM THE RESIDENTS ROOM AND REPORTED TO THE SAFETY NURSE. SHE CALLED ALLINA AND THEY SENT OUT A REPLACEMENT UNIT AND A REPLACEMENT UNIT FOR ANOTHER RESIDENT WHO HAD THE SAME NEBULIZER. NO VISIBLE DAMAGE NOTED TO NEBULIZER OR CORD. DEVICE SENT BACK TO ALLINA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLINA MINI NEBULIZER COMPRESSOR CAF MEDQUIP, INC. RCN-02WAA *

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR Required Intervention