Catalog Number MP000373 |
Device Problems
Gas Output Problem (1266); Obstruction of Flow (2423); Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/21/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The investigation was just started.The results will be provided in a follow-up report.
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Event Description
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It was reported that during the ongoing surgery, the patient could no longer be ventilated.After troubleshooting, it was found that the internal tubing of the coaxial system mp00373 was twisted and thus obstructed or prevented the flow of respiratory gas.The hose had been on the device since monday, (b)(6) 2021.No injury reported.
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Manufacturer Narrative
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For the investigation, the hose system in question was requested and provided.During the analysis at the manufacturer the described problem could be confirmed.It was found that the adhesive connection of the outer hose had come loose.This allowed the inner hose, which was firmly connected to the connector, to twist during use.An error during the bonding process in production was identified as the root cause.The adhesive is applied to the connector in a semicircle and distributed by circular movements when the hose is attached.Insufficient bonding of the hoses or a broken adhesive connection can result in reduced adhesion of the hose to the respective connector.This can additionally be favored by an insufficient amount of adhesive.The manufacturer has initiated additional training for employees regarding the bonding process and has ramped up visual inspection to 100% during packaging.The user is instructed in the instructions for use to inspect the breathing tube before use.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.
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Event Description
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It was reported that during the ongoing surgery, the patient could no longer be ventilated.After troubleshooting, it was found that the internal tubing of the coaxial system mp00373 was twisted and thus obstructed or prevented the flow of respiratory gas.The hose had been on the device since monday, 04/19/21.No injury reported.
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Search Alerts/Recalls
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