Medical Devices Risk Management, Quality, and Supply Chain Compliance Case Study Management Assignment Help

Assignment Task

Case Scenario:
Defibrillators are medical devices which are intended to restore a normal heartbeat by sending an
electric pulse or shock/current to the heart, and in situations where the heart suddenly stops.
A failure of DC (battery) power can result in a delay of defibrillation therapy if no AC (line) power
is available and the device will not operate. The manufacturer has recently started using critical
component materials from two Tier 1 vendors out of which one is located in the US, and other
Outside of US. The medical device manufacturer has reported to FDA a failure on the power
supply assembly which can result in either "No DC power" or "No DC or AC power." The
manufacturer has decided to recall all markets global inventory of this device. The reason behind
this decision was that the true account for floating inventory versus accounted had discrepancies
in total number of units and exact time duration (months) of market circulation. 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.
Assignment:
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.
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 defibrillator device and its probable
failure modes based upon the treatment use.
Attempt this assignment as a quality and risk assessment exercise. Include the following in your
analysis summary for the mock CAPA form.
 What are defibrillators 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.
 Include in your analysis and CAPA write-up, the following:
 Identify the issue
 Analyze
 Cause Analysis
 Proposed strategy for resolution

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