Quality Assurance Puritan Bennett 840: Hazards/ Warnings/ Recalls

1. Quality Assurance Puritan Bennett 840:Hazards/ Warnings/ Recalls Olina D’Souza (BSc., SRT), Kineta Snyder (SRT) Dalhousie School of Health Sciences – Respiratory Therapy

2. 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.

3. Methods used to research • Emergency care research institute (ECRI) • Food and Drug administration (FDA) • Pubmed • Covidien • Biomedical Department

4. 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

5. 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

6. Manufacturer upgrades

7. PB 840 Software • If a newer version of the PB840 software has been released, do all ventilators needs to be upgraded?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.

8. Patient Warnings • Audio • Visual • Do NOT press the alarm silence button and leave patient unattended

9. 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

10. 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

11. 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.

12. Operational Hazard

13. 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.

14. 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.

16. 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

18. 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

19. 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

20. Recalls

21. Capital District Health Authority (CDHA) - Reporting

22. CDHA reporting

23. CDHA - Reporting

24. 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?

25. 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.

26. 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.