TELEFLEX MEDICAL HUDSON CIRCUIT,(22MM),KRATON,DUAL HTD LIMBS; HUMIDIFIER, RESPIRATORY GAS, (
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Catalog Number 790-32 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/06/2017 |
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 the complaint could not be conducted since the device was not returned to the manufacturer at the time of this report.Device history record review shows that the product was assembled and inspected according to our specifications.Customer complaint cannot be confirmed based only on the information provided.If the device sample becomes available at a later date this report will be updated as applicable.
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Event Description
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Customer complaint alleges the device leaked during the short service test on the ventilator.Customer reports there was no patient involvement.
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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.In addition, no dimensional issues were identified.The sample met the current manufacturing specification.Functional testing was performed and the sample failed the leak test.The sample was then submerged in water and bubbles were observed, confirming there was a leak.The customer complaint is confirmed based on the functional inspection.The sample did not pass the leak test.A non-conformance report was initiated to complete and document the investigation and to provide corrective actions.
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Event Description
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Customer complaint alleges the device leaked during the short service test on the ventilator.Customer reports there was no patient involvement.
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Search Alerts/Recalls
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