Model Number 8300 |
Device Problem
Failure to Cycle (1142)
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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 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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It was reported that the device received 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 that they reconnected ferrite cable into power supply connector for channel error 571.6241.Replaced dented front case.Replaced etco2 door for it get stuck.Replaced corroded right iui.A review of the device history record showed the device had a manufacture date of 08/17/2017.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 s/n (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 (b)(6) which did not confirm similar complaints with the same or related failure mode for this customer.There were no existing capa¿s listed for any of the parts listed in this file for repair.
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Event Description
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It was reported that the device received error code 571.6241.There was no patient involvement.
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Event Description
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It was reported that the device received error code 571.6241.There was no patient involvement.
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Manufacturer Narrative
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The affected 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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Search Alerts/Recalls
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