BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPACT INSTRUMENTATION

    MDR report key: 298216 · Received September 25, 2000

    Report

    Report Number
    298216
    Event Type
    Injury
    Date Received
    September 25, 2000
    Date of Event
    September 17, 2000
    Report Date
    September 25, 2000
    Manufacturer
    IMPACT INSTRUMENTATION, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    VENTILATOR MALFUNCTIONING WHILE ON PT. TURNED OFF, WOULDN'T CALIBRATE AFTER IT WAS PLUGGED INTO A/C ADAPTOR. SMALL SPARK GENERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPACT INSTRUMENTATION MECHANICAL VENTILATOR CBK IMPACT INSTRUMENTATION, INC. UNI VENT 750 *

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Required Intervention