Newport HT70M-SY-EURecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10884521542105), received between Mar 15, 2017 and Aug 23, 2021 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 reports).

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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 23, 2021Sparking; Sparking

  IT WAS REPORTED THAT A SPARK IN THE ALTERNATING CURRENT (AC)/DIRECT CURRENT (DC) ADAPTER WAS OBSERVED FROM THIS HT70 VENTILATOR. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12354256 ↗
• MalfunctionApr 2, 2018Failure to Calibrate; Failure to Calibrate

  IT WAS REPORTED THAT THE HT70 VENTILATOR FRACTION OF INSPIRED OXYGEN (FIO2) CALIBRATION FAILED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7390353 ↗
• MalfunctionAug 23, 2017Device Sensing Problem; Device Sensing Problem

  THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT. THE SERVICE PROVIDER CHECKED THE VENTILATOR AND FOUND THE SINGLE BOARD COMPUTER (SBC) WILL NEED TO BE REPLACED.

  Patient problems: No Information; No Patient Involvement

  MAUDE report 6815291 ↗
• MalfunctionAug 23, 2017No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE HT70 VENTILATOR HAD FROZEN SCREEN. ALTHOUGH REQUESTED, IT IS UNKNOWN IF THE PATIENT WAS CONNECTED TO THE VENTILATOR AT THE TIME OF THE EVENT. 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 6814948 ↗
• MalfunctionAug 22, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Information; No Patient Involvement

  MAUDE report 6812263 ↗
• MalfunctionAug 9, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING MAINTENANCE, THE O2 SENSOR MALFUNCTIONED ON A HT70 VENTILATOR. THERE WAS NO PATIENT INVOLVEMENT AT THE TIME OF THE EVENT. MEDTRONIC WAS NOT AUTHORIZED TO EVALUATE/REPAIR THE DEVICE AS THE PRODUCT IS NOT IN MEDTRONIC CONTROL. THE REPAIR WAS 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 Patient Involvement

  MAUDE report 6777673 ↗
• MalfunctionAug 1, 2017Device Inoperable; Device Inoperable

  THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Information; No Patient Involvement

  MAUDE report 6758135 ↗
• MalfunctionJul 25, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE HT70 VENTILATOR HAD AN OXYGEN SENSOR ERROR. INFORMATION PERTAINING TO THE USE OF THE DEVICE AT THE TIME OF THE REPORTED EVENT AND PATIENT OUTCOME (IF APPLICABLE) HAS NOT BEEN PROVIDED. A SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND RE-CONNECTED ALL THE PNEUMATICS. OXYGEN SENSOR CALIBRATION WAS PERFORMED. THE UNIT PASSED ALL TESTING AND OPERATED WITHIN THE MANUFACTURING SPECIFICATIONS.

  Patient problems: No Information

  MAUDE report 6742518 ↗
• MalfunctionJul 12, 2017Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT THE HT70 VENTILATOR O2 SENSOR WAS OUT OF RANGE. NO PATIENT INVOLVEMENT WAS REPORTED. MEDTRONIC WAS NOT AUTHORIZED TO EVALUATE/REPAIR THE DEVICE AS THE PRODUCT IS NOT IN MEDTRONIC CONTROL. THE REPAIR WAS COMPLETED AT A NON-MEDTRONIC LOCATION AND THE SERVICE ENGINEER (SE) REPLACED THE AIR/OXYGEN MIXER. 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 Patient Involvement

  MAUDE report 6709092 ↗
• MalfunctionJul 12, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE HT70 VENTILATOR OXYGEN (O2) VALUE WAS UP TO 10% WHEN THE SETTING WAS AT 60-80%. THE VENTILATOR WAS NOT IN USE AT THE TIME OF REPORTED ISSUE. A SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND REPLACED THE MIXER. THE UNIT PASSED ALL TESTING AND OPERATED WITHIN THE MANUFACTURING SPECIFICATIONS.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 6708164 ↗
• MalfunctionJul 11, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE HT70 VENTILATOR HAD LEAKAGE, PATIENT INVOLVEMENT IS UNKNOWN. COVIDIEN WAS NOT AUTHORIZED TO EVALUATE/SERVICE THE DEVICE SO THE REPORTED COMPLAINT COULD NOT BE CONFIRMED.

  Patient problems: No Information

  MAUDE report 6703916 ↗
• MalfunctionJun 16, 2017Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT DURING INSTALLATION/SETUP THE HT70 VENTILATOR SCREEN FROZE AT THE SIX PICTURE SCREEN. THERE WAS NO PATIENT INVOLVEMENT AT THE TIME OF THE REPORTED CONDITION. THE SERVICE ENGINEER TROUBLESHOT THE ISSUE AND RECOMMENDED REPLACING THE SINGLE BOARD COMPUTER (SBC) BOARD.

  Patient problems: No Patient Involvement

  MAUDE report 6648956 ↗
• MalfunctionJun 16, 2017Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT THE HT70 VENTILATOR SCREEN FROZE. PATIENT INVOLVEMENT INFORMATION WAS NOT PROVIDED BY THE CUSTOMER. COVIDIEN/MEDTRONIC WAS NOT AUTHORIZED TO EVALUATE/SERVICE THE DEVICE SO THE REPORTED COMPLAINT COULD NOT BE CONFIRMED.

  Patient problems: No Information

  MAUDE report 6648803 ↗
• MalfunctionJun 16, 2017Low Readings; Low Readings

  THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Information; No Patient Involvement

  MAUDE report 6648290 ↗
• MalfunctionMay 2, 2017No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE HT70 VENTILATOR SCREEN CAN NOT BOOT UP COMPLETELY. THE CUSTOMER DID NOT PROVIDE PATIENT INVOLVEMENT INFORMA TION. THE SINGLE BOARD COMPUTER NEEDS TO BE REPLACED. REPAIR WILL BE COMPLETED AT A NON-MEDTRONIC LOCATION AND THE PRODUCT IS NOT IN MEDTRONIC CONTROL. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED WITHOUT THE PRODUCT RETURN.

  Patient problems: No Information; No Patient Involvement

  MAUDE report 6536385 ↗
• MalfunctionApr 18, 2017Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT THE HT70 VENTILATOR SCREEN WAS NOT BOOTING UP COMPLETELY, PATIENT INVOLVEMENT IS UNKNOWN. A NON COVIDIEN/ MEDTRONIC SERVICE INSPECTED THE DEVICE AND FOUND THAT THE SINGLE BOARD COMPUTER WAS DEFECTIVE. COVIDIEN/ MEDTRONIC WAS NOT AUTHORIZED TO EVALUATE/SERVICE THE DEVICE SO THE REPORTED COMPLAINT COULD NOT BE CONFIRMED.

  Patient problems: No Information; No Patient Involvement

  MAUDE report 6501089 ↗
• MalfunctionMar 15, 2017Device Inoperable; Device Inoperable

  IT WAS REPORTED THAT THE VENTILATOR'S TOUCHSCREEN WAS NOT WORKING. PATIENT INVOLVEMENT INFORMATION WAS NOT PROVIDED BY THE CUSTOMER. REPAIR WILL BE COMPLETED AT A NON-MEDTRONIC LOCATION AND THE PRODUCT IS NOT IN MEDTRONIC CONTROL. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED WITHOUT THE PRODUCT RETURN. THE COMPLAINT WILL BE CLOSED AND REOPENED/UPDATED SHOULD NEW INFORMATION BECOME AVAILABLE OR IF THE PRODUCT IS RETURNED TO THE MANUFACTURER FOR INVESTIGATION. THE INFORMATION HAS BEEN ADDED TO THE DATABASE FOR TRENDING PURPOSES AND TRENDS WILL CONTINUE TO BE MONITORED. A CAPA IS NOT REQUIRED AT THIS TIME.

  Patient problems: No Information

  MAUDE report 6407869 ↗

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