Catalog Number PFSR200027 |
Device Problems
Device Difficult to Program or Calibrate (1496); Intermittent Communication Failure (4038)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/29/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Internal complaint reference case- (b)(4).Initial reporter postal code (b)(6).
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Event Description
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It was reported that, during a navio sales training, they received a tracking failure of camera upon start up.It progressed as green through ankle collection but as circumduction of hip occurred, tracking failure error came up and camera remained in warming phase.They restarted several times and same error occurred.They tested on alternative navio system and same error happened.No case involved; therefore, there was no patient involvement.
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Manufacturer Narrative
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The ndi camera polaris spectra 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 completed.The reported problem was confirmed.Upon startup, a tracking failure of camera was received.The camera was connected to a navio system and a case created.The camera infrared failure error displayed and the camera remained in warming phase.An event file assessment was completed.The reported problem was confirmed.The event log identified numerous illuminator current faults.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 of these events is an electrical failure of the internal infrared camera led board.The camera is an oem product and cannot be disassembled further to arrive at a root cause.A historical capa, hhe/pra, field action review was completed.A review of prior escalation actions found no actions applicable to the scope of this case.The failure mode and associated risk have been anticipated within the risk file and that 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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Manufacturer Narrative
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The ndi camera polaris spectra 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 completed.The reported problem was confirmed.Upon startup, a tracking failure of camera was received.The camera was connected to a navio system and a case created.The camera infrared failure error displayed and the camera remained in warming phase.An event file assessment was completed.The reported problem was confirmed.The event log identified numerous illuminator current faults.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 of these events is an electrical failure of the internal infrared camera led board.The camera is an oem product and cannot be disassembled further to arrive at a root cause.A historical capa, hhe/pra, field action review was completed.A review of prior escalation actions found no actions applicable to the scope of this case.The failure mode and associated risk have been anticipated within the risk file and that 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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Search Alerts/Recalls
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