Class 2 Device Recall Protective Cover (Part No. 006344) for Vivo 50, Vivo 55, Vivo 60 and Vivo 65 ventilators

• Date Initiated by Firm: January 28, 2020
• Create Date: February 24, 2020
• Recall Status: Terminated on September 15, 2020
• Recall Number: Z-1352-2020
• Recall Event ID: 84828
• 510(K)Number: K160481
• Product Classification: Continuous, ventilator, home use - Product Code NOU
• Product: Protective Cover Vivo 55/65 (Used for Vivo 50/65), Part No. 006344. It is an accessory (i.e. protective cover) for the Vivo 50 and Vivo 65 ventilators - Product Usage: The protective cover is intended for additional protection of the Vivo 50, Vivo 55, Vivo 60 and Vivo 65 ventilators during transportation, and in hospital, institutional, and home care environments. It can be used while the Vivo ventilators is operating, for example mounted on a wheelchair, in a personal vehicle, or carried by hand. The device is not to be used with the protective cover while positioned in a warm place, such as in direct sunlight or close to a radiator. The protective cover includes the following features: transparent window for accessing front panel and buttons; port for patient circuit, cables, O2 inlet, and standby button; cooling air inlet; patient air inlet; straps for safe mounting; and cooling air outlet.
• Code Information: The cover does not have a lot number; these covers were distributed between 01/11/2018 and 12/17/2019
• FEI Number: 3010817335
• Recalling Firm/ Manufacturer: Breas Medical, Inc.; 16 Esquire Rd; North Billerica MA 01862-2527
• For Additional Information Contact: Angelea Rizzo; 855-436-8742
• Manufacturer Reason for Recall: The outlet hole of the exhalation valve control pressure tube on the ventilator may become obstructed by the protective cover.
• FDA Determined Cause: Device Design
• Action: On January 28, 2020, the firm began distributing Urgent Medical Device Correction letters to affected customers. Customers were informed of the product issue and associated risk of hypercarbia caused by excessive CO2 build-up (rebreathing). Customers were instructed to do the following: " Identify users/patients who use Protective Covers (p/n 006344) with a Vivo 50 or Vivo 65 ventilators. The model of ventilator can be determined from the device label on the bottom cover. Vivo 50 units have part no 215000 and Vivo 65 units have part no 226500. " Check if the Protective Cover is used with an exhalation valve circuit or dual-limb circuit. If this is the case, the users should be advised to take note of Rebreathing alarms and Exhalation Valve Control Error alarms. If any of these alarms occur, the small hole at the back cover of the ventilator may be obstructed. This may be resolved by ensuring that no force is applied to the front or back side of the Protective Cover. " Please notify Breas Medical of your preferred solution from the options below. " Please fill out and return the attached Reply Form at your earliest convenience and latest 29 February 2020. " Please forward this notice to anyone to whom you may have further distributed the product (additional consignees). Breas offers two options/solutions, which can be combined. 1. Advise users of the Protective Covers to be observant of the Rebreathing alarms and Exhalation Valve Control Error alarms and inform them that if these alarms occur, the small hole at the back cover of the ventilator may be obstructed. This can be resolved by ensuring that no force is applied to the front or back side of the Protective Cover. With this precaution, the Protective Covers can continue to be used. 2. If a user prefers, Breas offers to replace Protective Covers (p/n 006344) with new Protective Covers free-of-charge. We can provide you up to the number of the Protective Covers purchased according to our reco
• Quantity in Commerce: 629
• Distribution: Worldwide distribution - US Nationwide distribution in the states of AR, CA, FL, GA, IA, IL, KS, MA, MI, MO, NJ, NY, OH, PR, SC, TX, VA, WI and countries distribution worldwide.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = NOU