Model Number 8300 |
Device Problems
Computer Software Problem (1112); Failure to Calibrate (2440)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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The customer reported issue was confirmed.The device was repaired, retested, and released back to the customer.A review of the device history record in sap for sn (b)(4) was performed from the date of the manufacture to date of the release of product, which confirmed that this device was not involved in a production failure, and product was returned for servicing which correlates to the customer reported issue.A trackwise complaint history review was completed, and it was confirmed that there were additional complaints received with similar sn (b)(4) for the same or related failure mode.There was no patient involvement.
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Event Description
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Soft fault.Failed test in oridion board.Channel errors when attached to pcu- (b)(4).There was no patient involvement.
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Event Description
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Soft fault failed test in oridion board.Channel errors when attached to pcu- (b)(6) 2019 08:48:29 (b)(6) cad - po = $0.(b)(6).Shipping & billing addresses confirmed.Npi.*per (b)(6) (cad), the unit is npi and can go directly to service.There was no patient involvement.
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Manufacturer Narrative
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The customer reported issue was confirmed.The device was repaired, retested, and released back to the customer.A review of the device history record in sap for sn (b)(6) was performed from the date of the manufacture to date of the release of product, which confirmed that this device was not involved in a production failure, and product was returned for servicing which correlates to the customer reported issue.A trackwise complaint history review was completed, and it was confirmed that there were additional complaints received with similar sn (b)(6) for the same or related failure mode.There was no patient involvement.
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Search Alerts/Recalls
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