Model Number 8300 |
Device Problems
Device Alarm System (1012); Pumping Stopped (1503)
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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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Although requested, 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 alarm - error codes / messages.Giving 571.6241 error.There was no patient involvement.
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Manufacturer Narrative
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Updated d9 as product was received.The affected device 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 alarm - error codes / messages.Giving 571.6241 error.There was no patient involvement.
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Event Description
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The customer reported alarm - error codes / messages.Giving 571.6241 error.There was no patient involvement.
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Manufacturer Narrative
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Additional information: e1.
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Event Description
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The customer reported alarm - error codes / messages.Giving 571.6241 error.There was no patient involvement.
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Event Description
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The customer reported alarm - error codes / messages.Giving 571.6241 error.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 that error code 571.6241 is confirmed due to a cable j3 to power board loosen up.It's possibly jarring during the transport, reseated the cable j3.Performed leak down test and co2 calibration with passing results.Based on the findings, service was unable to determine the probable cause of the reported issue.A review of the device history record showed the device had a manufacture date of 18dec2015.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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Search Alerts/Recalls
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