Model Number 8100 |
Device Problem
Failure to Cycle (1142)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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A review of the complaint history record was performed for the sn (b)(4) which did not confirm similar complaints with the same or related failure mode for this customer.A review of the device history record showed the device had a manufacture date of 21may2019.The review was performed from the date of manufacture to the date of product release for distribution.A review of the device history record for sn (b)(4) was performed which confirmed that this device was not involved in a production failure which correlates to the customer reported issue.
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Event Description
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It was reported that the device has a logic board issue.No additional information was provided.There was no patient involvement.
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Event Description
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It was reported that the device has a logic board issue.No additional information was provided.There was no patient involvement.
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Manufacturer Narrative
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A review of the complaint history record was performed for the (b)(6) which did not confirm similar complaints with the same or related failure mode for this customer.A review of the device history record showed the device had a manufacture date of 21may2019.The review was performed from the date of manufacture to the date of product release for distribution.A review of the device history record for sn15580152 was performed which confirmed that this device was not involved in a production failure which correlates to the customer reported issue.
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Event Description
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It was reported that the device has a logic board issue.No additional information was provided.There was no patient involvement.
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Search Alerts/Recalls
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