Catalog Number 1115 |
Device Problem
Kinked (1339)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Information (3190)
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Event Date 08/15/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).It is unknown if the device sample is available for evaluation.A visual, functional, and dimensional inspection of the product involved in the complaint could not be conducted since the product was not returned.No picture available for review.The device history record of batch number (b)(4) that belong to catalog number 1115 has been reviewed and no issues or discrepancies were found which could potentially be related to this complaint.No non conformance reports were originated for the lot in question that can be associated to the complaint reported.Dhr shows that the product was assembled and inspected according to our specifications.Customer complaint cannot be confirmed based only on the information provided, to perform an investigation and determine the source of defect reported it is necessary to evaluate the sample involved in this customer complaint.However material from the production line was inspected and no issues were detected that can lead this customer complaint.If the device sample becomes available at a later date this complaint will be re-opened.
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Event Description
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The customer alleges that the oxygen tubing kinks and occludes and prevents the delivery of oxygen to the patient.The kink/occlusion is at the point of attachment.The customer, also, indicates that the tubing is connected to an oxygen cylinder or flow meter and when pulled tightly there is kinking.
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Manufacturer Narrative
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(b)(4).The sample was returned for evaluation.A visual exam was performed and no kinked tubing was observed.Based on the visual exam, the reported complaint could not be confirmed.There were no issues found with the returned sample.
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Event Description
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The customer alleges that the oxygen tubing kinks and occludes and prevents the delivery of oxygen to the patient.The kink/occlusion is at the point of attachment.The customer, also, indicates that the tubing is connected to an oxygen cylinder or flow meter and when pulled tightly there is kinking.
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Search Alerts/Recalls
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