Newport HT70PM-WW-EURecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521542259), received between Jun 22, 2017 and Aug 2, 2019 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

3 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.

Recalls naming this device

1. May 21, 2025Class IOpen, Classified

   Ventilator Printed Circuit Board Assembly may have two separate capacitors that may fail, which may result in the ventilator either shutting down during use, thus necessitating use of an alternate form of ventilation, or the shutdown alert alarm fails to alarm effectively during shut down, which may result in respiratory failure, hypoventilation, low oxygen saturation, hypoxia, treatment delay.

   Z-1915-2025 · Root cause: Component design/selection · Recall details · FDA record ↗

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.

• MalfunctionAug 2, 2019Smoking; Device Sensing Problem; Smoking; Device Sensing Problem

  IT WAS REPORTED THAT THE HT70 VENTILATOR¿S ALARM SILENCE RESET BUTTON AND LED (LIGHT-EMITTING DIODE) WERE NOT FUNCTIONING.

  Patient problems: No Patient Involvement

  MAUDE report 8855716 ↗
• InjurySep 29, 2017Device Inoperable; Device Inoperable

  IT WAS REPORTED DURING USE, THE HT70 PLUS VENTILATOR SWITCHED OFF SUDDENLY AND HAD A BLANK SCREEN. THE PATIENT WAS AT HOME WHEN THE VENTILATOR SUDDENLY STOPPED AND THE PATIENT WAS SHIFTED TO THE HOSPITAL BY POLICE AMBULANCE. THE PATIENT WAS NOT HARMED OR INJURED AS A RESULT OF THE REPORTED EVENT. THE SCREEN WAS REPLACED AND THE UNIT WAS UPGRADED WITH LATEST SOFTWARE, HOWEVER THE SCREEN FROZE.

  Patient problems: No Code Available

  MAUDE report 6905675 ↗
• MalfunctionAug 11, 2017Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE HT70 PLUS VENTILATOR HAD VISUAL ALARM DISPLAYING ¿REPLACE COIN BATTERY¿. ALTHOUGH REQUESTED, INFORMATION PERTAINING TO THE USE OF THE DEVICE AT THE TIME OF THE REPORTED EVENT AND PATIENT OUTCOME (IF APPLICABLE) HAS NOT BEEN PROVIDED. MEDTRONIC WAS NOT AUTHORIZED TO EVALUATE/REPAIR THE DEVICE AS THE PRODUCT IS NOT IN MEDTRONIC CONTROL. THE REPAIR WILL BE COMPLETED AT A NON-MEDTRONIC LOCATION. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED WITHOUT THE PRODUCT RETURN. SHOULD NEW INFORMATION BECOME AVAILABLE OR IF THE PRODUCT IS RETURNED TO THE MANUFACTURER FOR INVESTIGATION THE COMPLAINT WILL BE RE-EVALUATED.

  Patient problems: No Information

  MAUDE report 6790136 ↗
• MalfunctionJun 22, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE HT70 VENTILATOR UP AND DOWN ARROW DID NOT WORK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 6662034 ↗

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-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