Newport HT70M-JP-NA (UDI 10884521543942)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521543942), received between Mar 1, 2019 and Feb 7, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “No Flow” (3 reports).

4 other recalls cover devices cleared under the same FDA submission (K111146); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 7, 2023Defective Alarm; Defective Alarm

  IT WAS REPORTED THAT  WHEN THE CIRCUIT WAS REMOVED FROM THE PATIENT TO PERFORM SUCTION, THE ALARM ON THIS HT70 VENTILATOR DID NOT SOUND. THE PATIENT WAS NOT HARMED AS A RESULT OF THE REPORTED EVENT. ALTHOUGH REQUESTED, PATIENT INTERVENTION IS UNKNOWN AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16315598 ↗
• MalfunctionAug 30, 2021No Flow; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE VENTILATION STOPPED SUDDENLY ON THIS HT70 VENTILATOR. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITHOUT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12384754 ↗
• MalfunctionMar 1, 2019No Flow; No Flow

  IT WAS REPORTED THAT DURING USE ON A PATIENT, THE HT70 VENTILATOR GENERATED A CONTINUOUS WARNING SOUND SHUTDOWN ALARM. WHEN THE NURSE CHECKED THE VENTILATOR, THE DISPLAY BECAME BLACK AND VENTILATION STOPPED. UPON STARTING UP THE VENTILATOR, A SYSTEM ERROR WAS DISPLAYED. THE PATIENT WAS SWITCHED TO MANUAL VENTILATION AND THEN TRANSFERRED TO AN ALTERNATE VENTILATOR WITH NO PATIENT HARM.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 8383712 ↗
• MalfunctionMar 1, 2019No Flow; No Flow

  IT WAS REPORTED THAT DURING USE ON A PATIENT, THE HT70 VENTILATOR GENERATED A SYSTEM ERROR AND VENTILATION STOPPED. THE DEVICE WAS REPLACED WITH NO HARM TO THE PATIENT.

  Patient problems: No Code Available

  MAUDE report 8383694 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111146. One submission often covers many models, so check the product and lot details in each record.

• Z-1915-2025 · May 21, 2025 · Open, Classified
  Newport HT70 Ventilator, REF: HT70M-JP-NA, HT70M-CN-NA, HT70M-ES-EU, HT70M-PT-BR, HT70M-SY-EU, HT70M-WW-EU, HT70M-WW-NA, HT70-SY-EU. Newport HT70Plus Ventilator, REF: HT70PM-ES-EU
• Z-1874-2017 · Mar 30, 2017 · Terminated
  Newport Medical HT70 and HT70- Plus Ventilators, Rx Only Product Usage: The Newport HT70 family of ventilators is intended to provide continuous or intermittent positive pressure
• Z-1171-2013 · Apr 5, 2013 · Terminated
  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
• Z-2250-2012 · Aug 3, 2012 · Terminated
  Newport HT70 and HT70 Plus Ventilators, Model Number: HT70 and HT70 Plus. Product Usage: The HT70 ventilator system is intended to provide continuous or intermittent positive pre