Catalog Number 5705 |
Device Problems
Insufficient Heating (1287); Power Problem (3010)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/04/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The investigation into this complaint is still in progress.
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Event Description
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Customer complaint alleges "the unit will come on and heat up, but its not providing the "continuous heated aerosol for cpap therapy breathing treatments.It did work when they received it, but this past weekend it just stopped working and the power light doesn't come on anymore." alleged issue detected during 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 and forwarded to the manufacturer (pegasus) for evaluation.The manufacturer reports that upon receipt of unit the claim was not confirmed.The power switch did not illuminate when turned on, but unit did generate heat.Evaluation revealed that heater's power switch lamp was at fault.The component was inspected and did not present any visible defect, and the 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 these units, especially at this age (223 days approximately).The power switch was replaced and the heater was retested as per procedure and found to meet specifications.The unit was repaired and returned.
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Event Description
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Customer complaint alleges "the unit will come on and heat up, but its not providing the "continuous heated aerosol for cpap therapy breathing treatments.It did work when they received it, but this past weekend it just stopped working and the power light doesn't come on anymore." alleged issue detected during use.There was no report of patient impact or consequence.
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Search Alerts/Recalls
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