BEUDAMED
    FDA Adverse Event Death Summary report: N

    WOCHER, MAX & SON, CO

    MDR report key: 93646 · Received May 30, 1997

    Report

    Report Number
    93646
    Event Type
    Death
    Date Received
    May 30, 1997
    Date of Event
    April 23, 1997
    Report Date
    May 30, 1997
    Manufacturer
    WOCHER, MAX & SON, CO
    Product Code
    JCX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PT DID HAVE A CARDIAC ARREST DUE TO AN ALLERGIC REACTION. THIS SUCTION MACHINE WAS USED TO ASPIRATE HER MOUTH WHEN SHE WAS INTUBATED. IT DID NOT WORK. THIS MACHINE DID NOT CAUSE HER DEATH. AN ALTERNATE MACHINE WAS USED AND SHE WAS INTUBATED. FROM HOSP'S INVESTIGATION, THIS ASPIRATOR DID NOT CAUSE HER DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WOCHER, MAX & SON, CO ASPIRATOR JCX WOCHER, MAX & SON, CO * *

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death