Model Number 8300 |
Device Problem
Physical Resistance/Sticking (4012)
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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 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 received an ecom send/receive timeout error.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 replaced oridion pcb for error 570.6200.Replaced broken front case.A review of the device history record showed the device had a manufacture date of (b)(6) 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 sn (b)(6) was performed which confirmed that this device was 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 electrical failure of the bd assy oridion etco2 v1 rohs.A review of the complaint history record in trackwise and sap was performed for the sn (b)(6) which 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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The customer reported that the device received an ecom send/receive timeout error.There was no patient involvement.
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Search Alerts/Recalls
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