NULL PORTEX GENERAL ANESTHESIA CIRCUITS; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
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Model Number C45101340-NLJ |
Device Problem
Material Split, Cut or Torn (4008)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/25/2022 |
Event Type
malfunction
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Event Description
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It was reported that during the pre-use check, the breathing bag got torn.No patient injury was reported.
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Manufacturer Narrative
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One (1) picture was provided; a top view of damage to the bag was observed.A returned sample was received torn, confirming the complaint.It was concluded that failure reported could not be reproduced in the manufacturing process.A root cause cannot be associated with the manufacturing process since the failure reported could not be reproduced using the tools from assembly and packaging.The damage must have occurred after the product left the facility.No corrective actions were taken since the investigation did not reveal that the defect was caused during the manufacturing process.No lot number was provided for performance of a device history record review.
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