The actual device was received for evaluation.Visual and functional testing was performed.The c02 pump worked as intended.The reported complaint was not duplicated.The device history record (dhr) review is not applicable or relevant because the results of the complaint investigation do not indicate a problem with the initial manufacture or prior repair of the device.Due to wear of life, the co2 pump had reached the end of its useful life after approximately 6 years of consistent operation.As a result, a fault could not be assigned.The root cause is normal wear and tear.Non-healthcare professional this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
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