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Model Number 8300 |
Device Problems
Break (1069); Crack (1135); Failure of Device to Self-Test (2937)
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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 problem was confirmed.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 review of the complaint history record in the trackwise was performed for the sn (b)(4) which confirmed no similar complaints with the same or related failure mode.The customer stated that there was no patient involvement.
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Event Description
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Broken/damaged.Oridion board- failed- bit test.Damaged/cracked in case front, case rear.Iui- cracked housing, iui- isolation rib damage, broken/damaged (b)(4).
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Search Alerts/Recalls
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