Model Number IPN041365 |
Device Problem
Obstruction of Flow (2423)
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Patient Problem
Insufficient Information (4580)
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Event Date 05/16/2023 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Other remarks: n/a.Corrected data: n/a.
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Event Description
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The report states that "the hole of the device in the filter used to detect the hypercapnia line was occluded.The consequence was that the hypercapnia was impossible to detect during intubation process." at the time of this report, the customer has not returned our multiple requests for additional information.If further information is received, the complaint file will be updated.
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Manufacturer Narrative
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Qn#(b)(4).The sample was returned and sent to the manufacturing site for investigation.The manufacturing site reports "based on the investiga tion conducted on the returned sample, luer port of the complaint product housing has occluded by the housing material.The mentioned product housing was supplied by our supplier, and hence supplier corrective action request (scar) and nc has been issued, root cause analysis and identified corrective actions will be implemented through this scar.Assembly process will be conducted in our manuf acturing site for the product after receive the part item from supplier." other remarks: n/a.Corrected data: n/a.
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Event Description
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The report states that "the hole of the device in the filter used to detect the hypercapnia line was occluded.The consequence was that the hypercapnia was impossible to detect during intubation process." at the time of this report, the customer has not returned our multiple requests for additional information.If further information is received, the complaint file will be updated.
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Search Alerts/Recalls
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