Model Number 101/860/075 |
Device Problem
Obstruction of Flow (2423)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/01/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Month and year of event have been provided, day is unknown.A product sample was received and is awaiting evaluation, investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
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Event Description
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It was reported that when the customer was putting air in the pilot balloon, a strong physical resistance back from the product was felt.No patient injury was reported.
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Manufacturer Narrative
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Other, other text: h6 conclusion codes: updated.H10 device evaluation: two decontaminated samples were returned for investigation.Under visual inspection the samples appeared to be in good condition.Functional testing then inflated both samples by spare syringe.No problem was found - both devices were smoothly inflated.A dhr review was not conducted as no fault was found and the product functioned as intended.No action taken at this time.
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Search Alerts/Recalls
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