SERVO-i Ventilator System Maquet Critical Care, Solna, Sweden. The product is intended for treatment and monitoring of patients in the range of neonates, infants and adults with respiratory failure or respiratory insufficiency.
Hazard
Maquet became aware of potentially defective crimpings at the point connector attached to the cable in SERVO-i and SERVO-s ventilators.
What You Should Do
Remedy
Urgent - Device Correction notices were sent out to all customers on July 7, 2008. The letter informed the customers of the affected product, and associated hazards. The letter instructed customers to take an inventory of the product and it provided actions to be taken until affected products are replaced. Contact Maquet at 1-888-627-8383#1, for assistance.
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Products
SERVO-i Ventilator System Maquet Critical Care, Solna, Sweden. The product is intended for treatment and monitoring of patients in the range of neonates, infants and adults with respiratory failure
- Brand
- MAQUET Inc.
- UPC
- Article number 64 87 800 Serial numbers: 34034, 34035, 34050, 34052, 34053, 34054, 34058, 34060 through 34083, 34085, 34086, 34087, 34088, 34090, 34096, 34099 through 34287, 34293, 34294, 34295, 34296, 34298, 34299, 34302, 34303, 34305, 34309, 34313, 34315, 34319, 34230, 34323, 34324, 34326, 34329, 34330, 34343, 34345, 34348, 34350, 34357, 34360, 34376, 34384, 34390, 34427, 34490, and 34530.
Units Affected
122 units (SERVO-i and SERVO-s) units in United States