Model Number 8300 |
Device Problems
Failure to Read Input Signal (1581); Gas/Air Leak (2946)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
malfunction
|
Manufacturer Narrative
|
The affected devices have not been received.A follow up report will be submitted with investigation results should the devices be received for evaluation.
|
|
Event Description
|
It was reported that the device failed leak down test.No additional information was provided.There was no patient involvement.
|
|
Event Description
|
It was reported that the device failed leak down test.No additional information was provided.There was no patient involvement.
|
|
Manufacturer Narrative
|
This device was evaluated and repaired through the service repair process.Upon visual inspection the service technician confirmed leak down test failure due to oridion board and component was replaced accordingly.Front/rear case, and stuck et co2 outlet door were also replaced.Performed unit leak down test and passed co2 calibration results.Based on the findings, service determined that the reported issue was due to oridion board mechanical failure.Device history record a review of the device history record showed the device had a manufacture date of 28dec2009.The review was performed from the date of manufacture to the date of product release for distribution.A review of the device history record for sn (b)(6) was performed which confirmed that this device was not involved in a production failure which correlates to the customer reported issue.A review of the complaint history record was performed for the sn (b)(6) which did not confirm similar complaints with the same or related failure mode for this customer.
|
|
Search Alerts/Recalls
|