Catalog Number 100040 |
Device Problem
Deformation Due to Compressive Stress (2889)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/27/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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The complaint was reported as: "herniation of cuff noted on extubation of lma no ongoing concerns with patients.".No patient harm reported.The patient's condition was reported as "fine".
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Manufacturer Narrative
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Qn#(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the airway tube looked slightly yellowish due to multiple uses.The check valve was inspected and found to be functioning.No blockage was detected.The device was then inflated with 1x the recommended air volume and no herniation was visible on the cuff.The device was inflated again with 1.5x the recommended air volume and no issues were detected.A device history record review was performed and no relevant findings were identified.Based on the investigation performed, the reported complaint could not be confirmed.There was no herniation of the cuff when the device was inflated with 1x and 1.5x the recommended air volume.
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Event Description
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The complaint was reported as: "herniation of cuff noted on extuabtion of lma no ongoing concerns with patients.".No patient harm reported.The patient's condition was reported as "fine".
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Search Alerts/Recalls
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