Catalog Number 5705 |
Device Problems
Insufficient Heating (1287); Temperature Problem (3022)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/15/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device involved in this complaint has been returned to the manufacturer, however, the investigation of said device is still in progress at the time of this report.A follow up report will be submitted at the conclusion of the investigation.
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Event Description
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Customer complaint alleges the device failed to heat after being turned on for 20 minutes.Event reported as occurred during use for continuous nebulization.There was no report of patient injury or consequence.The patient condition was reported as "fine".
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Manufacturer Narrative
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Qn#(b)(4).The sample was returned for evaluation.The power switch did illuminate when turned on, but did not generate heat.Evaluation revealed that the heater's thermal-fuse was at fault.The component was inspected and did not present any visible defect, and dhr shows that the heater was operable and within specifications at the time of release.This is a random component failure, which is not often seen in this units, especially at this age (294 days approximately).The power switch was replaced and the heater was retested as per procedure and found to meet specifications.
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Event Description
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Customer complaint alleges the device failed to heat after being turned on for 20 minutes.Event reported as occurred during use for continuous nebulization.There was no report of patient injury or consequence.The patient condition was reported as "fine".
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Search Alerts/Recalls
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