Two bivona tracheostomy tube was returned for the evaluation of the reported issue.Based on details in the description, the complaint device was identified from the preferred device.A picture showing both labeled devices was sent to the complainant for confirmation.The devices were accurately identified.Placing the complaint sample on the manufacturing drawing showed that the curve aligned exactly.The complaint device was determined to have been manufactured to the template.Placing the preferred device on the drawing showed that the curve was more relaxed.The age, usage and cleaning history of the preferred device is unknown.To address the complainant's preference, drawing, zu21cn60nsb099, and rod were created from returned preferred sample.If the complainant, wants to order a device similar to the preferred device, a new template will need to be provided with the updated curve of 95 degrees.No fault was found and customer's complaint was unconfirmed.Using customer details provided in the complaint, the part number was determined to be zu17gn60nsb094s and the lot number was determined to be bs011464.
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