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Model Number SO-430 |
Device Problem
Connection Problem (2900)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 09/28/2023 |
Event Type
malfunction
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Manufacturer Narrative
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This would delay the treatment for the patient.
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Event Description
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The reservoir bag disconnected from the mask.
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Manufacturer Narrative
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This would delay the treatment for the patient.Complaint history reviewed.There have been 3 similar complaints in the previous 24 months for senko product.Senko product is manufactured as separate lot and not mixed with other material.Dhr review shows product passed sampling plan.Quality alert generated and training completed during the investigation with the multifunctional team, determined the root cause, and implemented the following corrective and preventative actions.Root cause: 1 operator performed manual assembly of the bag, tape and grommet 2 the operator did not detect that the tape and bag were assembled correctly during the assembly and packaging of the finished product.Corrective actions: 1 updated ai-700041 format to clarify placement of tape and bag in grommet.Dcr-13514 2 feedback was provided to line 6 personnel on the proper assembly of bags and grommet.Risk:(rma-20017a) r26: oxygen delivery interrupted - cannula components not bonded together securely - s=8 o=3 irpn=24 has a severity of (8/10) which meets the threshold of (8/10) for carb review.
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Event Description
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The reservoir bag disconnected from the mask.
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Search Alerts/Recalls
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