Model Number 8300 |
Device Problems
Device Sensing Problem (2917); Appropriate Term/Code Not Available (3191)
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Patient Problems
No Patient Involvement (2645); 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 device has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.
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Event Description
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The customer reported that the device received alarm - error codes / messages, 571.6240.
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Manufacturer Narrative
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Additional in d8, d9, h3, h6 the device has been received and an evaluation is pending.A follow up report will be submitted once the evaluation is completed.
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Event Description
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The customer reported that the device received alarm - error codes / messages, 571.6240.
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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 error code 571.6240 is confirmed due to cable j3 to power bard loosened up.It's possibly jarring during the transport.Reseated the cable j3.Performed leak down test and co2 calibration with passing results.A review of the device history record showed the device had a manufacture date of 18apr2014.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 cable j3 to power bard loosened up - reseated the cable (dropped/ error code 571.6240).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 received alarm - error codes / messages, 571.6240.
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Search Alerts/Recalls
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