The manufacturer received information alleging an unknown product problem.The patient alleges trouble breathing and very hard pain in their chest.Medical intervention was not specified.Additional information was received on sep-06-2022.The device was returned to manufacturer.During the evaluation of the device at the manufacturer's service center, the device was visually inspected and found no evidence of foam degradation.In addition, an error code related to the system board was found in the error log.The device's system board was replaced to address the issue.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
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