It was reported that, during a marketing demo, the red led light of the real intelligence tracking camera was flashing with a beep sound.No case involved; therefore, there was no patient involvement.
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H3, h6: the real intelligence tracking camera (singapore), rob10025, s/n (b)(6) intended for use in treatment was not returned for evaluation; thus, a visual and functional evaluation could not be performed and a relationship between the reported event and the device could not be established.Although the reported problem was not confirmed, a factor that may have contributed to the reported symptom may have been associated with the power source (battery) to the shock sensor circuit has disconnected itself from the shock sensor circuit during camera transport, resulting in the front camera leds blinking red and an audible beep.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.A historical escalation event review was not completed.The product was not returned and no evidence was made available to link the complaint to an escalation event.This 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, all complaints are monitored and trended through post market surveillance activities.
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