The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
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An evaluation of the kangaroo pump was performed.The unit was triaged, and the reported issue could not be confirmed at this time.The battery was replaced due to out of date, back housing damaged due to broken assembly, bump, hinge label, vynil foot, tyvek vent, and sn label were replaced due to back housing replacement.Also, the power connection label replaced due to opening the unit.No further actions are required at this time.Complaint trending information is being reviewed on a monthly basis and if a trend is observed, actions will be taken as necessary.
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