Events

Safety Alert for Product name: FAN MECHANICAL FAN Technical name: VENTILATOR PRESSURE AND VOLUME Registration number ANVISA: 10349000444 Hazard class: III Model affected: HT70, HT70 PLUS Serial numbers affected: N13HT721112868; N13HT721112875; N13HT721112873; N13HT721112849; N13HT721112880; N13HT721112884; N13HT721112877; N13HT721112883; N13HT721112878; N13HT721112879; N13HT721112881; N13HT721112885; N13HT721112871; N13HT721112874; N13HT721112865; N13HT721112867; N13HT721112861; N13HT721112858; N13HT721112856; N13HT721112866; N13HT721112848; N13HT721112857; N13HT721112855; N13HT721112850; N13HT721112853; N13HT721112864; N13HT721112872; N13HT721112852; N13HT721112882; N13HT721112876; N14HT700715782; N14HT700715786; N14HT700715790; N14HT700715798; N14HT700715784; N14HT700715806; N14HT700815821; N14HT700615756; N14HT700715800; N14HT700715783; N14HT700715795; N14HT700715793; N14HT700615729; N14HT700615744; N14HT700715789; N14HT700615747; N14HT700615727; N14HT700615728; N14HT700615731; N14HT700615736; N14HT700615742; N14HT700615748; N14HT700615752; N14HT700615753; N14HT700615755; N14HT700615738; N14HT700715785; N14HT700715787; N14HT700715788; N14HT700715791; N14HT700715792; N14HT700715796; N14HT700715799; N14HT700715804; N14HT700715805; N14HT700715807; N14HT700615732; N14HT700615733; N14HT700615734; N14HT700615735; N14HT700615737; N14HT700615739; N14HT700615740; N14HT700615741; N14HT700615743; N14HT700615745; N15HT720618303; N14HT720113096; N15HT720618301; N15HT720618293; N15HT720618290; N15HT720618309; N15HT720618302; N15HT720618292; N15HT720618295; N15HT720618327; N15HT720618298; N15HT720618420; N15HT720618421; N15HT720618418; N15HT720618419; N15HT720618341; N15HT720618319; N15HT720618308; N15HT720618318; N15HT720618307; N15HT720618422; N15HT720618306; N15HT720618317; N15HT720618330; N15HT720618344; N15HT720618342; N15HT720718387; N15HT720718389; N15HT720718388; N15HT720718369; N15HT720618325; N15HT720618343; N15HT720718391; N15HT720718390; N15HT720618334; N15HT720618336; N15HT720618339; N15HT720618340; N15HT720718424; N15HT720918560; N15HT720718427; N15HT720918559; N15HT720618316; N15HT720618332; N15HT720618323; N15HT720618313; N15HT720618333; N15HT720618304; N15HT720618315; N15HT720618314; N15HT720618331; N15HT720618329; N15HT720618312; N15HT720618322; N15HT720618324; N15HT720618326; N15HT720718423; N15HT720618311; N15HT720718385; N15HT720718370; N15HT720718368; N15HT720718437; N15HT720718378; N15HT720718381; N15HT720718380; N15HT720718383; N15HT720718426; N15HT720718384; N15HT720618310; N15HT720618321; N15HT720718374.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Auto Suture do Brasil Ltda; Newport Medical Instruments, Inc..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    2259
  • Date
    2017-04-07
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • Extra notes in the data
    Ensure patients assisted by the Newport ™ HT70 and HT70 Plus ventilators are properly monitored by trained nurses / caregivers as described in the Operator's Manual. Descriptions include: A patient connected to a ventilator requires constant attention from trained nurses / caregivers to the patient's condition. Always have a power supply and alternate ventilation means available when the fan is in use in the event of a mechanical or system problem. Always use appropriate monitors to ensure sufficient oxygenation and ventilation (such as a pulse oximeter and / or capnograph) when the Newport ™ HT70 or HT70 Plus ventilator is in use on a patient. If possible, use the remote nurse alarm call cord (CBL3223 or 10104494) to project the ventilator alarm states out of the patient's room. This alarm will be issued even with an unexpected restart. Refer to the Operator's Manual or call Technical Support for more information about this accessory.
  • Reason
    The purpose of this notice is to inform you that medtronic is issuing a voluntary corrective action notice to all its newport ™ ht70 and newport ™ ht70 plus fans after reports that the ventilator may on rare occasions restart spontaneously during normal operation without an alarm.
  • Action
    Field Action Code FAHT70 triggered under the responsibility of the company Auto Suture do Brasil Ltda. Company will make correction in the field.

Device

Product name: FAN MECHANICAL FAN Technical name: VENTILATOR PRESSURE AND VOLUME Registration numb...

Manufacturer

Auto Suture do Brasil Ltda; Newport Medical Instruments, Inc.
  • 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
    ANVSANVISA