Model Number 8100 |
Device Problems
Crack (1135); Imprecision (1307); Failure to Read Input Signal (1581); Appropriate Term/Code Not Available (3191)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.
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Event Description
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The customer reported that the device patient side occlusion test failed, customer states the device was way too low.There was no patient involvement.
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Event Description
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The customer reported that the device patient side occlusion test failed, customer states the device was way too low.There was no patient involvement.
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Manufacturer Narrative
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A review of the complaint history record in trackwise and sap was performed for the sn (b)(6) which did not confirm similar complaints with the same or related failure mode for this customer.A review of the device history record showed the device had a manufacture date of 15 may 2015.The review was performed from the date of manufacture to the date of product release for distribution.A review of the device history record in sap 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.
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Manufacturer Narrative
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This device was evaluated and repaired through the service repair process.Upon visual inspection the service technician noted that they replaced broken air in line which caused customer stated problem occlusion error.A review of the device history record showed the device had a manufacture date of 15 may 2015.The review was performed from the date of manufacture to the date of product release for distribution.A review of the device history record in sap 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.Based on the findings, service determined that the proximate cause of the reported issue was due to maintenance issue of the moog ail kit.A review of the complaint history record in trackwise and sap was performed for the sn (b)(6) which did not confirm similar complaints with the same or related failure mode for this customer.
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Event Description
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The customer reported that the device patient side occlusion test failed, customer states "it was way too low." there was no patient involvement.
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Search Alerts/Recalls
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