Model Number ROB10024 |
Device Problem
Computer Operating System Problem (2898)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/18/2022 |
Event Type
malfunction
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Event Description
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It was reported that, when the system arrived, the real intelligence tablet coupling was in pieces.The outer shell was unscrewed and the inner two pieces were off as well.After setting the system up, could not get it to reach the splash screen.At first, nothing would show up on the tablet, but after working at the coupling it got to the bios screen.That is what would show after booting up.Personal could not advance past this screen no matter what they did.It was attempted adjusting the items in the bios, so it was took off the cori top and then worked at the internal components, but still nothing worked as expected.As this was noticed a during demo lab, no patient was involved.
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Manufacturer Narrative
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Internal complaint reference: (b)(4).
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Manufacturer Narrative
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H3, h6: the real intelligence cori, part # rob10024, serial # (b)(6), intended for use in treatment, was returned for evaluation.A relationship between the reported event and the device was established.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed.The reported problem was confirmed.Testing determined that the tcu board was not receiving power due to a loose power connection wire.The most likely cause was a faulty wire crimp to the power connector.A review of manufacturing records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints found similar events.A historical escalation event review was completed.A review of prior escalation actions found no actions applicable to the scope of the reported complaint.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.Although no further containment or corrective action is recommended or required at this time, the failure mode will continue to be closely monitored through complaint investigation and trended through post market surveillance activities.
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Search Alerts/Recalls
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