BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDIQ VENTILATOR

    MDR report key: 108141 · Received July 14, 1997

    Report

    Report Number
    108141
    Event Type
    Injury
    Date Received
    July 14, 1997
    Date of Event
    July 3, 1997
    Report Date
    July 11, 1997
    Manufacturer
    MEDIQ PRN LIFE SUPPORT SERVICES
    Product Code
    CBK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    NURSE NOTICED VENTILATOR ALARMING, BUT WAS UNABLE TO DETERMINE THE CAUSE. PT'S 02 SATURATION 73%- 95% DURING INCIDENT. PT WAS BAGGED WITH 100% 02 WHILE VENTILATOR WAS BEING CHARGED. VENTILATOR WAS REPLACED AND PT SATURATION RETURNED TO 100%. EVENT WAS REPORTED TO RENTAL CO. VENTILATOR WAS SENT BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDIQ VENTILATOR VENTILATOR CBK MEDIQ PRN LIFE SUPPORT SERVICES 7200A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention