Continuous Ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device. A manufacturer has decided to recall all markets global inventory of this device. The reason of this recall was noted as: "the audible alarm may not sound and/or the device-directional LED visual alarm may not display during alarm states. Delayed awareness of alarm states may lead to delayed response or a delay of treatment, potentially resulting in hypoxia, dyspnea, cardiac arrest, or death". The quality team has made a proposal to complete a though investigation to determine the root case. To proceed the manufacturer has to notify the FDA and initiate a CAPA. Based upon the probable route for identification of the root cause the company will need to make a determination if this device issue requires preventative or corrective action, or both types.

Write a mock CAPA form explaining the reason for opening this action and the determination routes (preventative or corrective) that would be required. Take into consideration the QSR, Risk Analysis and Compliance Management as covered in the course modules. Consider the scenario as the company is planning a recall, it is critical to understand what issues could have triggered this type of action. Conduct a general web research on the continuous ventilator device category and its probable failure modes based upon the treatment use. Attempt this assignment as a real-world quality and risk assessment exercise. Include the following in your analysis summary for the mock CAPA form.  

What are continuous ventilator and the type of risk which could be associated with such devices.  

Define the risk index, taking into consideration the level of risk (1 -5).  Assess the probability of severity versus occurrence.  

Describe the probable root cause(s) which caused this issue leading to recall. - Add information per FDA Recall Database  Include in your analysis and CAPA write-up, the following:  

Identify the issue o Analyze o Cause Analysis o Proposed strategy for resolution o Proposed Root Cause Analysis.

Proposal for continuous improvement.  What is the status, i.e. Open or Closed Recall? 

What actions were taken and information provided to notify the customers?