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Model Number 72203967 |
Device Problem
Display or Visual Feedback Problem (1184)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Event Description
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It was reported that the camera head image went suddenly to a color bar.No case reported; therefore, there was no patient involvement.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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Manufacturer Narrative
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H10: d10, h2, h3, h6.The reported device, intended for use in treatment, was received for evaluation.There was no relationship found between the returned device and the reported incident.A visual inspection was performed on the exterior of the product and no physical damage was observed.The complaint of video output malfunction could not be duplicated during the functional testing process.The camera head passed functional testing and 2 hour burn-in inside test video tower.All functions perform as expected and live video image was normal.The complaint of color bar malfunction was not confirmed and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future occurrence of the reported event.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.
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Manufacturer Narrative
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The reported device, intended for use in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review found related failures; this failure mode will be trended to assess for any necessary corrective actions.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future occurrence of the reported event.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.
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Search Alerts/Recalls
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