Catalog Number C45091795D-NL |
Device Problem
Break (1069)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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It was reported that the bag was popping off during the procedure.
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Event Description
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There has been no report of patient involvement or no observable clinical symptoms or a change in symptoms identified in the patient.
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Manufacturer Narrative
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Other, other text: no lot number was provided; therefore, device history record review could not be performed.The returned samples were visually inspected; no damage was found.From the eight bags received, three passed the leak test; the other five failed.The leak was coming from the assembly with the bushing and the tape.The most probable root cause is production personnel did not detect the incorrect assembly of the tape.A quality alert was generated on 18-mar-2020 to ensure that operators can detect any incorrect assembly of tape on the breathing bags.Production personnel was trained in this quality alert.Since the lot number was not reported, it?s unknown if the product was manufactured after the implementation of these changes.No patient involvement.
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Event Description
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The reported issue involved a patient during procedure.No observable clinical symptoms or a change in symptoms identified in the patient.
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Manufacturer Narrative
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Other, other text: this mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
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Search Alerts/Recalls
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