BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PNEUPAC VENTIPAC WITH ALARMS

    MDR report key: 1558672 · Received November 18, 2009

    Report

    Report Number
    2182466-2009-00018
    Event Type
    Malfunction
    Date Received
    November 18, 2009
    Date of Event
    October 20, 2009
    Report Date
    October 20, 2009
    Product Code
    BTL
    PMA / PMN Number
    K030803
    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. (B)(4). 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 MFR. SMITHS MEDICAL PM, INC. WAS NOTIFIED OF THE ISSUE BY (B)(6), A CONTRACT BIOMEDICAL ENGINEERING COMPANY THAT SERVICES THE EQUIPMENT FOR (B)(4). (B)(4) SENT THE VENTILATOR TO (B)(6) FOR SERVICING AFTER THE ISSUE ALLEGEDLY OCCURRED. (B)(6) PROVIDED SMITHS MEDICAL PM, INC.'S REQUEST FOR ADD'L INFO TO (B)(4). NO ADD'L INFO HAS BEEN PROVIDED BY (B)(4) AT THIS TIME. (B)(4) REQUESTED THAT THE VENTILATOR BE RETURNED TO THEM FROM (B)(6) WITHOUT IT BEING REPAIRED. THE VENTILATOR IS CURRENTLY IN ROUTE TO SMITHS MEDICAL PM, INC. TECHNICAL SERVICE FOR EVALUATION.

    Description of Event or Problem · 1

    THE USER FACILITY, (B)(4), ALLEGES THE VENTILATOR STOPPED CYCLING WHILE ATTACHED TO A PT. THE VENTILATOR WAS RETURNED TO (B)(6) FOR REPAIR. NO KNOWN ADVERSE HEALTH CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PNEUPAC VENTIPAC WITH ALARMS EMERGENCY VENTILATOR BTL V200D

    Patients

    Seq Age Sex Outcome Treatment
    1