BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFE CARE PORTABLE

    MDR report key: 269266 · Received March 13, 2000

    Report

    Report Number
    269266
    Event Type
    Injury
    Date Received
    March 13, 2000
    Date of Event
    March 3, 2000
    Report Date
    March 10, 2000
    Manufacturer
    MEDIQ PRN LIFE SUPPORT SERVICES
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NEW LEASED VENTILATOR WAS BEING IMPLEMENTED TO REPLACE PREVIOUS VENDOR. VENTILATORS FOUND TO BE MALFUNCTIONING (INTERNAL FAILURE MALFUNCTION ALARM). UNIT IMMEDIATELY REPLACED WITH VENTILATOR OF PREVIOUS VENDOR. NO HARM TO RESIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFE CARE PORTABLE PORTABLE VENTILATOR CBK MEDIQ PRN LIFE SUPPORT SERVICES PLV102 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention