Adult Heart Cooling Jacket Recirculation Set QUALITY RECORD: DESIGN VALIDATION SURVEYAs part of our desire to serve you better and to address Health Canada regulatory requirements, we would appreciate your feedback on this product. After performing the product evaluation on the samples provided, please complete the survey below.Evaluation Description: To confirm that the product meets user requirements when it is used for its intended purpose.Product code: 17-260TGProduct Evaluation Quantity: Product Evaluation Lot Number: Hospital/Clinic Centre: Toronto General HospitalReviewer's Name:Questions1. Does the product perform as intended? Yes No 2. Does this product contain all the materials required to complete the procedure functionally and safely? Yes No 3. Does the document titled 'Instructions for Use' provide clear and concise directions? Yes No 4. Is the packaging and labeling suitable for this product? Yes No 5. Do the suture eyelets of the jacket facilitate better securement around the heart? Yes No 6. Is the jacket's shape acceptable in relation to the phrenic nerve? Yes No 7. Does the jacket have adequate flexibility to fit the shape of the heart? Yes No Please add any additional comments:The responses to this survey will be used for research and regulatory purposes only. DOCUMENT NO.: RD-001R27, REV. 03
