Catalog Number 050-14 |
Device Problems
Failure to Power Up (1476); Smoking (1585)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
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Event Date 12/01/2015 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).It is unknown if the device sample is available for evaluation.A visual, functional and dimensional inspection of the product involved in the complaint could not be conducted since the product was not returned.The device history record investigation did not show issues related to complaint.A document assessment (fmea) was conducted and no changes required.Corrective actions cannot be established since it is necessary to receive the device sample to perform a proper investigation and confirm the alleged defect.At this time since the device sample is not available it is not possible to determine the source of the defect reported.Customer complaint cannot be confirmed since the device sample is not available to perform a proper investigation and determine the root cause.If the device sample becomes available at a later date, this complaint will be updated accordingly.Telelfex will continue to be monitoring trending on similar complaints.
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Event Description
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The customer alleges that the device stated to smoke.The device was turned off and would not turn on again.
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Manufacturer Narrative
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(b)(4).The sample was returned for evaluation.A visual exam was performed and no issues were observed.Functional testing was also performed and the unit passed all tests.The unit heated up on the minimum, medium and maximum temperature setting during testing and the unit did not smoke.Based on the investigation performed, the reported complaint could not be confirmed.There were no issues found with the returned device.
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Event Description
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The customer alleges that the device stated to smoke.The device was turned off and would not turn on again.
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Search Alerts/Recalls
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