Catalog Number 048-91 |
Device Problems
Insufficient Heating (1287); Temperature Problem (3022)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/28/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).A visual, dimensional, and functional inspection of the device involved in the complaint could not be conducted since the device was not returned to the manufacturer at the time of this report.A device history record investigation did not show issues related to this complaint.A record review fmea-08-044 rev 00 was performed and the failure mode is already included.No update is required.Customer complaint cannot be confirmed based on the information received.Corrective actions cannot be established at this time.It is necessary to receive the device sample to perform a proper and thorough investigation to confirm the alleged defect reported and determine a root cause.If the device sample becomes available at a later date, this report will be updated accordingly.
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Event Description
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Customer complaint alleges the device is not heating.Alleged issue reported as detected prior to patient use during functional testing.There was no report of patient harm or delay in treatment.
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Manufacturer Narrative
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Qn#: (b)(4).The sample was returned for evaluation.A visual exam was performed and no defects 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.All aquatherm heaters are 100% inspected during manufacturing; therefore, a defect of this type would be detected prior to release from the manufacturing facility.It was determined that operational context caused or contributed to the reported defect.
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Event Description
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Customer complaint alleges the device is not heating.Alleged issue reported as detected prior to patient use during functional testing.There was no report of patient harm or delay in treatment.
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Search Alerts/Recalls
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