Catalog Number 5705 |
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 05/23/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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Customer complaint alleges the device will not heat up.Alleged issue reported as detected prior to a patient use.There was no report of patient impact or consequence.
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Manufacturer Narrative
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(b)(4).The sample was returned for evaluation.It was found that the thermal-fuse prevented the unit from generating heat.The thermal-fuse was replaced and the unit operated within specifications.The dhr show that the heater was working within specifications at the time of release.The approximate age of the heater is 93 days.Based on the investigation performed, the reported complaint was confirmed.The unit was repaired and returned.
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Event Description
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Customer complaint alleges the device will not heat up.Alleged isue reported as detected prior to a patient use.There was no report of patient impact or consequence.
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Search Alerts/Recalls
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