Catalog Number 5705 |
Device Problem
Intermittent Loss of Power (4016)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/20/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device involved has not been received for evaluation by the manufacturer at the time of this initial report.
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Event Description
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Customer complaint alleges the device stopped working 3 times on a patient after just 3 days of use.There was no patient harm reported.
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Event Description
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Customer complaint alleges the device stopped working 3 times on a patient after just 3 days of use.There was no patient harm reported.
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Manufacturer Narrative
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Qn# (b)(4).The unit was returned and sent to the manufacturer (pegasus research corp) for evaluation.Pegasus reports that "upon receipt of unit the claim was confirmed.Evaluation revealed that the thermal-fuse was opened and prevented the unit from heating.The thermal-fuse was replaced and the unit operated within specifications.Dhr show that the heater was working within specifications at the time of release.The approximate age of the heater is 284 days." based on the investigation performed, the reported complaint was confirmed.The unit was repaired and returned.
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Search Alerts/Recalls
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