Catalog Number 048-91 |
Device Problems
Insufficient Heating (1287); Temperature Problem (3022)
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Patient Problems
No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
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Event Date 07/26/2017 |
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 this complaint could not be conducted since the device was not returned at the time of this report.A device history record investigation did not show issues related to this complaint.A record assessment (fmea-08-043 rev 02) was reviewed and no update is required.Customer complaint cannot be confirmed based on the information received.It is necessary to receive the device sample to perform a proper investigation and confirm the alleged defect reported.Corrective actions cannot be established at this time.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 "aquatherm heater serial # (b)(4) is not heating up." there was no report of patient involvement.There was no report of patient harm.
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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 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 "aquatherm heater serial # (b)(4) is not heating up." there was no report of patient involvement.There was no report of patient harm.
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Search Alerts/Recalls
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