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Quality Assurance Puritan Bennett 840: Hazards/ Warnings/ Recalls. Olina D’Souza (BSc., SRT), Kineta Snyder (SRT) Dalhousie School of Health Sciences – Respiratory Therapy. Objectives. Describe the methods used to research. Define quality assurance (QA) . Describe the warnings.

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quality assurance puritan bennett 840 hazards warnings recalls

Quality Assurance Puritan Bennett 840:Hazards/ Warnings/ Recalls

Olina D’Souza (BSc., SRT), Kineta Snyder (SRT)

Dalhousie School of Health Sciences – Respiratory Therapy

objectives
Objectives
  • Describe the methods used to

research.

  • Define quality assurance (QA).
  • Describe the warnings.
  • Describe the hazards.
  • Describe how the RRT and Covidien tracks issues related to the PB 840.
methods used to research
Methods used to research
  • Emergency care research institute (ECRI)
  • Food and Drug administration (FDA)
  • Pubmed
  • Covidien
  • Biomedical Department
quality assurance
Quality Assurance
  • The international standards organization defines QA as:
    • Guidelines that can be used consistently to ensure materials, products, processes and services designed for specific purposes are fulfilled
history
History
  • PB 840 was introduced in 1998.
  • What is the process of ventilator launch?
    • Requirements set by design control need to be met in a pre-launch phase – i.e. trouble shooting the ventilator for worse case scenarios, patient stimulation
    • Once standards have been met in the pre-launch phase the ventilator is used in the post launch world – i.e hospital, ambulance, home-care environment
pb 840 software
PB 840 Software
  • If a newer version of the PB840 software has been released, do all ventilators needs to be upgraded?
    • Changes made to software are not mandatory. Facilities and depending on government regulations dictate if a newer software needs to be installed.
patient warnings
Patient Warnings
  • Audio
  • Visual
  • Do NOT press the alarm silence button and leave patient unattended
warnings pb 840 set up
Warnings: PB 840 set-up
  • Connect air source to air intake and oxygen source to oxygen intake
  • 2 gasses must be connected at all times
  • Connections to the ventilator must be clean, unlubricated and no water present in the air/oxygen supply gas
warnings pb 840
Warnings: PB 840
  • Use of low resistance circuits – high resistance circuits may not prevent ventilation but cause an SST fault and/or decrease patient’s ability to breathe through the circuit
  • Also, ensures optimal compliance compensation
  • Shock hazard – PB840 must be electrically connected to a grounded AC outlet
manufactures recommendations
Manufactures recommendations
  • The manufacturer provides specific recommendations related to the PB840 that clinicians are responsible for in order to ensure high QA.
  • What are regulations surrounding how often checks need to be run on the PB 840?
    • Manufacturer has obligation to provide details on the frequency of checks that should be run on PB840 to ensure the device is running properly.
operational hazards
Operational Hazards
  • December 2012 and Novemeber 2012- The customer reported that the 840 ventilator had a blank screen while in use on a patient. The patient was not harmed or injured as a result of the event. Covidienfigured out the problem with the customer over the phone. The customer was advised to replace the graphical interface unit (gui) cable.
operational hazards local issues
Operational Hazards – Local Issues
  • Recent problems with new Hudson RCI made by Teleflex medical circuit.
    • Connection seal between circuit and ventilator may cause the PB 840 to not pass the SST.
e lectromagnetic i nterference emi
Electromagnetic Interference (EMI)
  • Yes, that means cell phones!!
  • The manufacturer has identified four facilities in which the 840 ventilator stopped breath delivery and entered a safety-valve-open state on a patient.
  • Manufacture found that cell phones can created a disturbance when placed within a meter (3 ft) of the 840’s breath-delivery unit
patient hazards
Patient Hazards
  • Incorrect patient circuit type and humidification entered (when performing an SST, EST) will affect patient compliance, VT(exhaled)calculated
    • FIX: Rerun the test with correct circuit and humidification used
patient hazards1
Patient Hazards
  • Disconnect patient from the ventilator before running SST
  • Do not repeat an individual test with a different patient circuit if the SST result is ‘failure’ or ‘alert’
    • FIX: Restart SST from the beginning and ensure SST has been successfully completed
covidien q a
Covidien: Q & A
  • What types of questions are asked by Covidien when an issue with the ventilator (i.e. PB840) does arise?
    • Type of failure occurred ? Negative outcome to patient/ patients? Is this a one time issue or a recurrence? Is there a negative shift?
covidien q a1
Covidien: Q & A
  • How is a malfunctioned ventilator component tracked?
    • Many of the parts on a ventilator are serialized. If a part has malfunctioned and is sent to be repaired it is tracked via the serial number on the device.
  • How are records maintained?
    • Records are maintained in a database (i.e. FDA) that is publicly accessibly.
summary
Summary
  • Ensuring quality assurance is an essential component in the practice of Respiratory Care.
  • Questions about issues/ failures with equipment should be documented and reported in an effective manner to minimize personal and patient harm.
  • Issues with quality assurance may be found through the FDA, ECRI and company website.
  • Reports used in this quality assurance presentation were localized to the Capital Health District Authority, Halifax, Nova Scotia, Canada.