It was reported that no pressure traces were visible, and the equipment would not zero.The customer states that the issue could possibly be the transducers.The customer has tried single and double transducers but the transducers only work in two (2) of their four (4) labs.These events occurred over three days, twice during angioplasty and once during a right heart catheter assessment.One of the case issues caused the patient to be moved to another lab which resolved the issue.The other two events can be found in (b)(6).Customer states the device is not available for return.
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Other, other text: d4: lot number, expiration date, h4: manufacturing date no information provided to date, b3: month and year of event have been provided, day is unknown.No product was made available for investigation.If the sample is made available, we will reopen the file and send investigation results in a supplemental report.Device history review not completed as no lot number was provided.
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