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Model Number 8210 |
Device Problems
Break (1069); Circuit Failure (1089); Crack (1135)
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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.The device was repaired, retested, and released back to the customer.Infusion products global customer support operations.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 not returned for servicing which not 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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(b)(4).
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Manufacturer Narrative
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The customer reported problem was confirmed.The device was repaired, retested, and released back to the customer.Infusion products global customer support operations.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 not returned for servicing which not correlates to the customer reported issue.A review of the complaint history record in the trackwise was performed for the sn (b)(6) 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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Error code 410.603/sensor issue.Iui- isolation rib damage.Display board- failure.Damaged/cracked- case front, case rear.There was no patient involvement.(b)(4).
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Search Alerts/Recalls
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