Model Number 8210 |
Device Problems
Break (1069); Circuit Failure (1089); Contamination (1120); Failure to Power Up (1476)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/21/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The actual date of event is unknown.A follow up report will be submitted with investigation results should the device be repaired or the device/logs be received for evaluation.
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Event Description
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It was reported that the device won't turn on and case was broken.There was no patient involvement.
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Event Description
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It was reported that the device won't turn on and case was broken.There was no patient involvement.
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Manufacturer Narrative
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A review of the complaint history was performed which did not confirm similar complaints with the same or related failure mode.A review of the device history record was performed from the date of manufacture to the date of product release for distribution which confirmed that this device was not involved in a production failure which correlates to the customer reported issue.A review of the service history record was performed which confirmed that this device was not involved in a service failure which correlates to the customer reported issue.
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Search Alerts/Recalls
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