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Model Number 72203967S |
Device Problem
No Display/Image (1183)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/30/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The reported device, intended for use in treatment, was returned for independent evaluation.There was a relationship found between the returned device and the reported incident.Visual inspection of the returned device did not identify any issues.Functional evaluation revealed there was no live video output.The complaint has been confirmed and the root cause has been associated with an electrical component failure.Factors, unrelated to the design or manufacture of the device which could have contributed to the complaint event, include a failed image sensor.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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Event Description
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It was reported that, the camera head was not working.No case reported; therefore, there was no patient involvement.Results of investigation have concluded that this unit had no live video which makes it a reportable event.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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Search Alerts/Recalls
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