Events

Recall of Newport Medical Instruments HT70 and HT70 Plus ventilator Power Pac batteries

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Newport Medical Instruments Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    64851
  • Event Risk Class
    Class 1
  • Event Number
    Z-1171-2013
  • Event Initiated Date
    2013-04-05
  • Event Date Posted
    2013-04-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-03-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117179
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Ventilator, continuous, facility use - Product Code CBK
  • Reason
    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.
  • 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.

Device

Newport Medical Instruments HT70 and HT70 Plus ventilator Power Pac batteries
  • Model / Serial
    Model number: HT70 and HT70 Plus  Power Pac battery serial number range: 2096134110001 to 2292048120050, Rev. C through Rev. F
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product Description
    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.
  • Manufacturer
    Newport Medical Instruments Inc

Manufacturer

Newport Medical Instruments Inc
  • Manufacturer Address
    Newport Medical Instruments Inc, 1620 Sunflower Ave, Costa Mesa CA 92626-1513
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA