BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PNEUPAC PARAPAC WITH ALARMS

    MDR report key: 1060751 · Received June 13, 2008

    Report

    Report Number
    2182466-2008-00005
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    May 13, 2008
    Report Date
    June 13, 2008
    Manufacturer
    SMITHS MEDICAL PM, INC.
    Product Code
    BTL
    PMA / PMN Number
    K020899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    SMITHS MEDICAL PM, INC IMPORTS THE VENTILATOR FROM SMITHS MEDICAL INTERNATIONAL, LTD. SMITHS MEDICAL PM, INC KITS A PT CIRCUIT AND REGULATOR AND PACKAGES IT WITH THE VENTILATOR, THEREFORE, SMITHS MEDICAL PM, INC IS REPORTING AS THE MANUFACTURER. THE VENTILATOR WAS EVALUATED BY THE USER FACILITY BIOMEDICAL ENGINEERING DEPT AND THE FAILURE MODE COULD NOT BE REPRODUCED. THE VENTILATOR HAS NOT BEEN RETURNED TO SMITHS MEDICAL PM, INC TECHNICAL SERVICE DEPT FOR EVAL. NO CONCLUSION CAN BE DRAWN AT THIS TIME. MULTIPLE ATTEMPTS HAVE BEEN MADE TO RECEIVE ADD'L INFO FROM CLINICIANS AT THE USER FACILITY. NO RESPONSE HAS BEEN RECEIVED. WE WILL CONTINUE TO CONTACT THE USER FACILITY TO OBTAIN MORE INFO AND TO HAVE THE VENTILATOR RETURNED FOR EVAL.

    Description of Event or Problem · 1

    CUSTOMER ALLEGES THE UNIT STOPPED VENTILATOR A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PNEUPAC PARAPAC WITH ALARMS EMERGENCY VENTILATOR BTL SMITHS MEDICAL PM, INC. P200D

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention