Date rec'd from mfr: 19nov2019.The customer confirmed the reported calibration table issue.The customer reported that the vent was not repaired.The controller pcb was no longer available.I have removed the ventilator from service completely.The determination could be made that the device failed to meet specifications.The device was not being used for treatment when the reported event occurred, and there is a relationship of the device to the reported problem.Part was not returned to failure investigation (fi).The root cause cannot be determined until the device is returned and investigated.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
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