BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PNEUPAC VR1 STANDARD

    MDR report key: 1031304 · Received April 17, 2008

    Report

    Report Number
    2182466-2008-00003
    Event Type
    Malfunction
    Date Received
    April 17, 2008
    Report Date
    April 17, 2008
    Manufacturer
    SMITHS MEDICAL PM, INC.
    Product Code
    BTL
    PMA / PMN Number
    K051322
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    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 MFR. THE UNIT WAS RETURNED TO SMITHS MEDICAL PM, INC. TECHNICAL SERVICE DEPT AND WAS EVALUATED. THE SERVICE DEPT FOUND THAT THE INSPIRATORY TIME WAS EXCESSIVELY LONG. THE UNIT APPEARED TO NOT CYCLE ABOVE DETENT BUT WILL CYCLE WHEN SET BELOW DETENT. THE UNIT WAS SENT TO SMITHS MEDICAL INTERNATIONAL, LTD TO BE EVALUATED. WE ARE AWAITING THE RESULTS.

    Description of Event or Problem · 1

    THE UNIT WAS INSTALLED IN AN AMBULANCE AND NOT ATTACHED TO A PT. BEFORE IT WAS USED, THE AMBULANCE TECHNICIANS CHECKED THE DEVICE'S OPERATION AND NOTICED IT WAS ALLEGEDLY NOT FUNCTIONING PROPERLY (WILL NOT CYCLE). THE DEVICE WAS THEN SET ASIDE, SO IT COULD NOT BE USED ON A PT. THE ALLEGED FAILURE WAS NOT IMMEDIATELY REPORTED TO THE SMITHS MEDICAL PM, INC. TECHNICAL SERVICE DEPT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PNEUPAC VR1 STANDARD EMERGENCY VENTILATOR BTL SMITHS MEDICAL PM, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1