BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPACT INSTRUMENTATION, INC.

    MDR report key: 301231 · Received October 20, 2000

    Report

    Report Number
    301231
    Event Type
    Injury
    Date Received
    October 20, 2000
    Date of Event
    October 9, 2000
    Report Date
    October 18, 2000
    Manufacturer
    IMPACT INSTRUMENTATION
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PT BEING VENTILATED WITH DEVICE. WITH 30 MINUTES OF BATTERY LIFE REMAINING, BATTERY ALARM WENT OFF. TWO MINUTES LATER, SYSTEM FAILURE ALARM WENT OFF AND VENTILATOR SHUT OFF. MANUAL DEVICE WAS PRESENT AND IMMEDIATELY INITIATED TO VENTILATE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPACT INSTRUMENTATION, INC. MODEL 754 EAGLE UNI-VENT CBK IMPACT INSTRUMENTATION 754 *

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Life Threatening| R