Model Number ROB10025 |
Device Problem
Intermittent Communication Failure (4038)
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Patient Problems
No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/04/2020 |
Event Type
malfunction
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Event Description
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It was reported that, during a cori installment, the camera had green lights on the back showing power/connection, but a red blinking light with audible beep on the front.When entering the camera diagnostic function within cori, the camera was not recognized.Cat5 cable was checked throughout the system and it did not show any visible defects.A new cat5 cable was tested which resulted in more of the same.No patient was involved.
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Manufacturer Narrative
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G3, h2, h3, and h6: the cori camera p/n rob10025 s/n (b)(6) intended for use in treatment was returned for evaluation.A relationship between the reported event and the device was established.Nothing visually contributed to the reported problem.A functional evaluation was performed.The reported problem was confirmed.The red blinking indicator was present.It is a result of a shock sensor that has been disabled due to the shock sensor battery loosing contact with the battery holder.The shock sensor was reset/enabled to clear the blinking indicator.A camera accuracy verification was performed and passed.The camera then functioned without any errors.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints has identified prior events.The most likely cause can be attributed to the shock sensor becoming disabled during transportation.Although no further containment or corrective action is recommended or required at this time, all complaints are monitored and trended through post market surveillance activities.B5: update summary, d10: add concomitants, h6: update codes.
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Event Description
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It was reported that during a cori installment, the camera had green lights on the back showing power/connection, but a red blinking light with audible beep on the front.When entering the camera diagnostic function within cori, the camera was not recognized.Cat5 cable was checked throughout the system and it did not show any visible defects.A new cat5 cable was tested which resulted in more of the same.No patient was involved.No other complications were reported.
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Search Alerts/Recalls
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