Ge healthcare's investigation into the reported occurrence is still ongoing.A follow-up report will be issued when the investigation has been completed.No report of patient involvement.The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.Device evaluation anticipated, but not yet begun.
|
The customer opened a service case requesting a technical inspection and report of the system's status in order to ensure that the ventilator was working properly.A ge healthcare service representative performed a checkout of the system and a review of the logs.The checkout results, functional tests, error, event, and alarm logs were reviewed.No errors were found.The system was found 100% functional and working properly.Ge healthcare product engineering performed an investigation of this event.The customer did not allege that the machine failed.Engineering review of the logs indicates there was no malfunction of the device, it performed as intended, and there was no evidence of user error.Because there was no allegation of failure and no functional fault found, this event was not reportable.
|