BEUDAMED
    FDA Adverse Event Death Summary report: N

    AIR-SHIELDS

    MDR report key: 213015 · Received February 26, 1999

    Report

    Report Number
    213015
    Event Type
    Death
    Date Received
    February 26, 1999
    Date of Event
    November 9, 1998
    Report Date
    February 22, 1999
    Manufacturer
    AIR-SHIELDS
    Product Code
    JCX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    "THE ASPIRATOR MALFUNCTIONED DURING CODE." BIOMEDICAL STAFF WAS CALLED TO EVALUATE ASPIRATOR AFTER IT WAS TAKEN OUT OF SERVICE. IT WAS LEARNED THAT THE HOSING WAS WRONGLY CONNECTED TO THE AIR OUT PORT RATHER THAN THE SUCTION PORT AT THE TIME OF THE CODE WITH A RESULT OF NO AVAILABLE SUCTION DURING THE CODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIR-SHIELDS ASPIRATOR, TROCHE (FREESTANDING) JCX AIR-SHIELDS EC *

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death