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U.S. Department of Health and Human Services

Class 1 Device Recall Newport Medical Instruments HT70 and HT70 Plus ventilator Power Pac batteries

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 Class 1 Recall
Newport Medical Instruments HT70 and HT70 Plus ventilator Power Pac batteries
see related information
Date Posted April 26, 2013
Recall Status1 Open
Recall Number Z-1171-2013
Recall Event ID 64851
Premarket Notification
510(K) Numbers
K090888  K111146 
Product Classification Ventilator, Continuous, Facility Use - Product Code CBK
Product Newport Medical Instruments HT70 and HT70 Plus ventilator Power Pac batteries Model number: HT70 and HT70 Plus. The HT70 and HT70 Plus ventilator systems are intended to provide continuous or intermittent positive pressure mechanical ventilatory support for the care of individuals who require mechanical ventilation through invasive or non-invasive interfaces.
Code Information Model number: HT70 and HT70 Plus Power Pac battery serial number range: 2096134110001 to 2292048120050, Rev. C through Rev. F
Recalling Firm/
Manufacturer
Newport Medical Instruments Inc
1620 Sunflower Ave
Costa Mesa, California 92626-1513
Manufacturer Reason
for Recall
Newport Medical Instruments is conducting a voluntary recall on certain Newport Medical Instruments HT70 and HT70 Plus ventilator Power Pac batteries due to customer reports of Newport HT70 and HT70 Plus ventilators alarming and going to internal backup battery sooner than expected while the ventilator is being operated on Power Pac battery.
FDA Determined
Cause 2
DESIGN: Component Design/Selection
Action Newport Medical Instruments sent an Urgent Medical Device Recall letter dated April 4, 2013, via FedEx to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers who sold the affected product to another party, or placed the affected product with a patient or healthcare provider were instructed to immediately inform the other party, patient, or healthcare provider of this action and provide them with a copy of the letter. If customers were using the affected product, they should ensure that an alternate source of power is available nearby. Customers were instructed to report any issues with Newport" HT70 and HT70 Plus ventilators or Power Pac batteries to the Technical Support group to ensure proper device reporting procedures are followed. Please call 800-451-3111, extension 500, for U.S. customers; and 714-427-5811, extension 500 for international customers and you will be given further instructions). For questions regarding this recall call 714-427-5811, ext 344. A press release was issued by the firm on 04/18/13.
Quantity in Commerce 2528 ventilators and 1864 power pac batteries
Distribution Worldwide Distribution - USA including US (AL, AR, AZ, CA, CO, CT, DE, FL, GA, lA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NH, NJ, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, TN, TX, UT, VA, WA, and WI. Internationally to Argentina, Australia, Bangladesh, Belgium, BoliVia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Ecuador, Egypt, France, Greece, Hong Kong, Hungary, India, Indonesia, Israel, Ireland, Italy, Japan, Kazakhstan, Kosova, Lebanon, Lithuania, Malaysia, Mexico, Nambia, Nepal, Norway, Oman, Paraguay, Peru, Philippines, Poland, Qatar, Saudi Arabia, Singapore, South Africa, South Korea, Sri Lanka, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Viet Nam.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = CBK and Original Applicant = NEWPORT MEDICAL INSTRUMENTS, INC.
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