Catalog Number 048-91 |
Device Problems
Failure to Power Up (1476); Power Problem (3010)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/11/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Qn#(b)(4).A visual, functional, and dimensional inspection of the product involved in the complaint could not be conducted since the product was not returned.A device history record review was conducted no issues were found related to the complaint.A document assessment (fmea) was conducted and no changes required.Corrective actions cannot be established since it is necessary to receive the physical 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.
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Event Description
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The customer alleges that the unit stopped working and would not power back on.The patient's condition is reported as fine.
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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 performed; however, a current test could not be performed due to an open circuit.It is possible that the open circuit was due to overheating of the unit.Based on the investigation performed, the reported complaint was confirmed.Although the complaint was confirmed, a root cause for the issue could not be determined.All aquatherm heaters are 100% tested at the manufacturing facility; therefore, a defect of this type would be detected prior to release.A conclusion code could not be chosen as the complaint was not confirmed; however, a root cause was not established.
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Event Description
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The customer alleges that the unit stopped working and would not power back on.The patient's condition is reported as fine.
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Search Alerts/Recalls
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