(b)(4).Method: the complaint opt970 was not returned to fisher & paykel healthcare in new zealand.Our investigation is based on our knowledge of the product and information provided by the hospital.Results & conclusion: we were unable to determine the cause of the reported fault.The hospital stated the patient sometimes coughs violently or has seizures and it is possible that the disconnection occurred during these events.All optiflow interfaces are inspected during production for visual defects including cracks, tears, inclusions, discolouration and stretching or deformation.Any product that fails the visual inspection is disposed of.Additionally, the 900pt551 hbt forms a tight fit with the opt900 series interface and requires over 15 newtons of force in order to disconnect it from the interface.During manufacture, samples of the hbt connector are tested with the opt series cannulae to ensure that the required disconnection force is greater than 15 newtons.The user instructions which accompany the opt970 state to "connect to the humidification system.Make sure all connections are secure" and warn that "appropriate patient monitoring must be used at all times.Failure to monitor the patient may result in loss of therapy, serious injury or death.".
|