Newport DLHT70PM-WW-NARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521208940), received between Aug 13, 2019 and Aug 13, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “No Flow” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2019No Flow; Pressure Problem; No Flow; Pressure Problem

  THE REPORTER STATED THAT A PRE-INTUBATION CHEST X-RAY WAS OBTAINED SHOWING NO PNEUMOTHORAX. THE PATIENT WAS INTUBATED AND PLACED ON THE HT70 VENTILATOR WHICH BEGAN MAKING A ¿POPPING NOISE¿ FROM THE EXHALATION VALVE AND GENERATED HIGH PRESSURE ALARMS. IT WAS REPORTED THAT THE PATIENT HAD NO CHEST RISE AND DESATURATED. THE PATIENT WAS BAGGED AND PLACED ON AN ALTERNATE VENTILATOR. A FOLLOW UP CHEST X-RAY SHOWED A TENSION PNEUMOTHORAX. AFTER PATIENT TRANSFER, THE STAFF POWERED THE VENTILATOR BACK ON AND ATTEMPTED TO RUN A CIRCUIT CHECK WHICH DID NOT PASS.

  Patient problems: Low Oxygen Saturation; Pneumothorax

  MAUDE report 8888010 ↗

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