A device was returned to a third-party service center in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap,and mechanical ventilator devices.The manufacturer received information wrong setting.There was no report of patient harm or injury.The device was returned to a third-party service center for investigation.During the evaluation of the device, the third-party service center visually inspected the device and found evidence of foam degradation.The customer's complaint was also confirmed.In addition to the above findings, there were also technical findings setting change for rico.The device was scrapped.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.
|