Model Number 8300 |
Device Problems
Device Alarm System (1012); Crack (1135); 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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It was reported that the device displayed the error code 571.6241.There was no patient involvement.
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Manufacturer Narrative
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The device has been received and an evaluation is pending.A follow up report will be submitted once the evaluation is completed.H3 other text : the device has been received and an evaluation is pending.
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Event Description
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It was reported that the device displayed the error code 571.6241.There was no patient involvement.
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Manufacturer Narrative
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The reported issue was confirmed.This device was evaluated and repaired through the service repair process.Upon visual inspection the service technician noted a loose cable causing the issue.The cable was reseated and the case was replaced.The device was calibrated and passed a leak down test.Based on the findings, service determined that the proximate cause of the reported issue was due to a loose cable.A review of the device history record showed the device had a manufacture date of 26 jan 2011.The review was performed from the date of manufacture to the date of product release for distribution.A review of the device history record 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, 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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It was reported that the device displayed the error code 571.6241.There was no patient involvement.
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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 571.6241 was confirmed due to a cable j3 to power board loosen up.Reseated the cable j3.Also found damaged rear case at bottom.Replaced it a new rear case assembly.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 26 jan 2011.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 a loose cable.A review of the complaint history record in trackwise and sap was performed for the sn (b)(6) which confirmed similar complaints with the same or related failure mode for this customer.
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Event Description
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It was reported that the device displayed the error code 571.6241.There was no patient involvement.
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Search Alerts/Recalls
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