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Newport HT70M-CN-NARecalls & reported problems

Newport Medical Instruments, Inc. · HT70 VENTILATOR, W/O2 SENSOR, CHINESE · 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
4
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521542044), received between May 17, 2017 and Jan 14, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (2 reports).

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

  • Battery Problem2
  • Erratic or Intermittent Display1
  • No Flow1

Patient problems

  • No Patient Involvement3
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionJan 14, 2022No Flow; No Flow

    IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THIS HT70 VENTILATOR SHUT DOWN AND COULD NOT BE RESTARTED. THE PATIENT WAS PLACED ON AN ALTERNATE VENTILATOR WITHOUT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13259621 ↗
  • MalfunctionJul 30, 2017Battery Problem; Battery Problem

    IT WAS REPORTED THAT DURING START UP THE HT70 VENTILATOR ALARM GENERATED A " DATE HAS RESET PLEASE REPLACE COIN BATTERY" MESSAGE. THERE WAS NO PATIENT INVOLVEMENT. THE SERVICE ENGINEER REPLACED THE COIN BATTERY AND THE CONTROL PRINTED CIRCUIT BOARD. THE VENTILATOR WAS FOUND TO BE IN WORKING CONDITION.

    Patient problems: No Patient Involvement

    MAUDE report 6753142 ↗
  • MalfunctionJun 8, 2017Erratic or Intermittent Display; Erratic or Intermittent Display

    IT WAS REPORTED THAT THE HT70 VENTILATOR HAD A BLACK SCREEN AFTER REPLACEMENT OF THE SINGLE-BOARD COMPUTER (SBC) BOARD. THERE WAS NO PATIENT INVOLVEMENT AT THE TIME OF THE REPORTED CONDITION.

    Patient problems: No Patient Involvement

    MAUDE report 6621828 ↗
  • MalfunctionMay 17, 2017Battery Problem; Battery Problem

    IT WAS REPORTED THAT A HT70 VENTILATOR GENERATED A REPLACE BACKUP BATTERY ALARM. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE VENTILATOR WAS EVALUATED BY A THIRD PARTY SERVICE ENGINEER AND THE CUSTOMER REPORTED ISSUE WAS CONFIRMED. TO RESOLVE THE ISSUE, THE CONTROL BOARD WAS REPLACED. THE VENTILATOR WORKS NORMALLY. REPAIR WAS 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 Patient Involvement

    MAUDE report 6573497 ↗

Other VENTILATOR, CONTINUOUS, FACILITY USE devices

All VENTILATOR, CONTINUOUS, FACILITY USE devices →

Sources and updates

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