Model Number IPN041365 |
Device Problem
Incorrect Measurement (1383)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/02/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Qn#(b)(4).Other remarks: n/a.Corrected data: n/a.
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Event Description
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It was reported that "the luer lock hub was non-functional.It was impossible to read/analyze the gases used in anesthesia.There was no capnography on the ventilator during anesthesia induction.Same after changing the capnometry sensor line".No patient harm or injury.The patient status is reported as "fine".
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Manufacturer Narrative
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Qn#(b)(4).The sample was returned and sent to the manufacturing site for evaluation.The manufacturing site reports that a visual exam was performed and it was observed that the luer port was occluded.The manufacturing site also reports "complaint reported that no capnography on the ventilator during anesthesia induction.Based on the investigation 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 manufacturing 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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It was reported that "the luer lock hub was non-functional.It was impossible to read/analyze the gases used in anesthesia.There was no capnography on the ventilator during anesthesia induction.Same after changing the capnometry sensor line".No patient harm or injury.The patient status is reported as "fine".
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Search Alerts/Recalls
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