Skip to content

Newport HT70M-ES-EURecalls & reported problems

Newport Medical Instruments, Inc. · HT70 Ventilator With Accessories;O2 Monitor · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521542051), received between Aug 18, 2017 and Aug 23, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (1 report).

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

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

Device problems

  • Device Displays Incorrect Message1
  • No Display/Image1

Patient problems

  • No Patient Involvement2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 23, 2017No Display/Image; No Display/Image

    IT WAS REPORTED THAT DURING THE SERVICING, THE HT70 VENTILATOR DID NOT PASS PRE-DELIVERY INSPECTION (PDI). IT WAS REPORTED THAT THE PROBLEM WAS IN THE SOFTWARE. THE VENTILATOR WAS TURNED ON AND THE SCREEN REMAINED IN START MODE WITHOUT RESPONSE OF ANY CONTROL. THERE WAS NO PATIENT INVOLVEMENT AT THE TIME OF THE REPORTED EVENT. 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 6813809 ↗
  • MalfunctionAug 18, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

    IT WAS REPORTED THAT DURING SERVICING, THE HT70 VENTILATOR GENERATED AN ERROR ¿TIME IN USE¿. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED 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 Patient Involvement

    MAUDE report 6805087 ↗

Other VENTILATOR, CONTINUOUS, FACILITY USE devices

All VENTILATOR, CONTINUOUS, FACILITY USE devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page