Device product
Maquet Servo-I Ventilator System -EDI CATHETER PHT Free 6Fr/49cm 5/pkg Product Code/REF Number: 6685775 Product Usage: The Edi Catheter is a single-use naso-gastric feeding tube with an electrode array of ten electrodes. The Edi Catheter is intended for: - Detecting diaphragmatic electrical activity, (Edi signals) by which the two ventilator modes NAVA and NIV NAVA can be controlled. - Detecting diaphragmatic electrical activity, (Edi signals) by which the respiratory drive from the brain can be monitored. - administrating nutrition, fluids and medications by the naso-gastricenteric route.
Z-1221-2019
Product summary
- Event
- Event 82533
- Status
- Terminated
- Classification
- Class III
- Quantity
- 17 boxes (5 catheters per box)
- Official record key
device-enforcement:Z-1221-2019
Official wording
Reason: Edi Catheter labeled with wrong expiry date on single pack EDI catheter boxes
Code information: Lot Number: 92265355 UDI Code: 6685775: 07325710002100
Distribution pattern: Worldwide distribution - US nationwide in the states of FL, NC and countries of AT, FR, HC, PO.
Derived failure modes
-
Unknown
Edi Catheter labeled with wrong expiry date on single pack EDI catheter boxes