Newport HT70PM-WW-NA (UDI 10884521544413)Recalls & reported problems
Newport Medical Instruments, Inc. · HT70 Ventilator with Accessories Plus Model · 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.
Quick summary
This Newport HT70 ventilator is a facility-use breathing machine. Most of the 75 reports describe it failing to deliver air flow or failing to turn on, along with power and battery charging problems, alarms that did not sound, and calibration failures; the reports involved 3 injuries and no deaths, and many events happened while the unit was not on a patient. One open recall, started in May 2025, covers a circuit board with capacitors that may fail, which can shut the ventilator down or silence its shutdown alert.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 75
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 75 adverse event reports that list this exact device (DI 10884521544413), received between Jun 3, 2017 and Aug 8, 2025 — classified as 3 injuries, 72 malfunctions.
The most frequently reported specific device problem is “No Flow” (38 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.
Reports received per month
Recalls naming this device
- 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
- No Flow38
- Power Problem15
- Defective Alarm6
- Battery Problem5
- Device Operates Differently Than Expected5
- Failure to Calibrate5
- No Display/Image3
- Output Problem3
Patient problems
- No Clinical Signs, Symptoms or Conditions31
- No Patient Involvement28
- No Consequences Or Impact To Patient13
- No Code Available6
- No Known Impact Or Consequence To Patient2
- Low Oxygen Saturation1
- No Information1
Recent adverse event reports
The 25 most recent of 75 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 8, 2025Product Quality Problem; No Flow; Product Quality Problem; No Flow
DURING REPAIR FOR REPORTED EVENT THAT THE HT70 VENTILATOR WOULD NOT TURN ON, THE REPLACED NEW CONTROL BOARD FAILED OUT OF BOX. 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 22758918 ↗MalfunctionAug 8, 2025No Flow; Power Problem; No Flow; Power Problem
IT WAS REPORTED THAT THE HT70 VENTILATOR WOULD NOT TURN ON. 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 22758308 ↗MalfunctionJul 11, 2025Defective Alarm; Defective Alarm
IT WAS REPORTED THAT THE HT70 VENTILATOR DID NOT HAVE A POWER OFF ALARM. 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 22484705 ↗MalfunctionJun 9, 2025Defective Alarm; Failure to Calibrate; Defective Alarm; Failure to Calibrate
IT WAS REPORTED THAT THIS HT70 VENTILATOR DID NOT PASS CALIBRATION. 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 22168529 ↗MalfunctionFeb 25, 2025Failure to Charge; No Flow; Failure to Charge; No Flow
IT WAS REPORTED THAT THE HT70 VENTILATOR'S INTERNAL BATTERY WOULD NOT CHARGE. 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 21461438 ↗MalfunctionSep 20, 2024Defective Alarm; Defective Alarm
IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE PERFORMED BY CUSTOMER, THIS HT70 VENTILATOR DID NOT GENERATE A SHUT DOWN ALARM. 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 20269083 ↗MalfunctionSep 4, 2024No Flow; Power Problem; No Flow; Power Problem
IT WAS REPORTED THAT THIS HT70 VENTILATOR DID NOT POWER ON. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED E VENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20140760 ↗MalfunctionJun 11, 2024No Flow; Output Problem; No Flow; Output Problem
IT WAS REPORTED THAT THIS HT70 VENTILATOR DID NOT PASS OPERATIONAL VERIFICATION PROCEDURE (OVP). 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 19515504 ↗MalfunctionMay 24, 2024No Flow; Power Problem; No Flow; Power Problem
IT WAS REPORTED THAT THE HT70 VENTILATOR WAS SHUTTING DOWN BY ITSELF. 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 19397528 ↗MalfunctionMay 24, 2024No Flow; No Flow
IT WAS REPORTED THAT THE HT70 VENTILATOR WAS SHUTTING DOWN BY ITSELF. 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 19397480 ↗MalfunctionApr 18, 2024No Flow; Power Problem; No Flow; Power Problem
IT WAS REPORTED THAT THIS HT70 VENTILATOR TURNS OFF DURING SELF-TEST AND IT WILL NOT TURN ON. 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 19137909 ↗MalfunctionApr 11, 2024No Flow; Power Problem; No Flow; Power Problem
IT WAS REPORTED THAT THIS HT70 VENTILATOR TURNED OFF. 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 19093480 ↗MalfunctionApr 4, 2024No Flow; No Flow
IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THIS HT70 VENTILATOR GENERATED A LOUD GRINDING NOISE AND THE PATIENT WAS UNABLE TO BREATH BECAUSE THE VENTILATION STOPPED. THE PATIENT EXPERIENCED A DECREASED OXYGEN SATURATION OF 60% FOR APPROXIMATELY TWO TO THREE MINUTES BUT RECOVERED AFTER PLACING ON AN ALTERNATE VENTILATOR WITHOUT INJURY.
Patient problems: Low Oxygen Saturation
MAUDE report 19047411 ↗MalfunctionJan 18, 2024No Flow; No Flow
IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE HT70 VENTILATOR SUDDENLY POWERED OFF. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND WAS PLACED ON AN ALTERNATE VENTILATOR WITHOUT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18536496 ↗MalfunctionNov 3, 2023No Flow; Power Problem; No Flow; Power Problem
IT WAS REPORTED THAT THIS HT70 VENTILATOR WILL NOT TURN ON. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED E VENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18065624 ↗MalfunctionApr 26, 2023No Flow; Power Problem; No Flow; Power Problem
IT WAS REPORTED THAT THIS HT70 VENTILATOR DID NOT TURN ON. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EV ENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16820779 ↗MalfunctionApr 26, 2023No Flow; Power Problem; No Flow; Power Problem
IT WAS REPORTED THAT THIS HT70 VENTILATOR DID NOT TURN ON. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EV ENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16820775 ↗MalfunctionFeb 28, 2023No Flow; Power Problem; No Flow; Power Problem
IT WAS REPORTED THAT THIS HT70 VENTILATOR WOULD NOT POWER ON. 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 16456494 ↗MalfunctionDec 27, 2022No Flow; Power Problem; No Flow; Power Problem
IT WAS REPORTED THAT THE HT70 VENTILATOR DID NOT POWER ON. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EV ENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16053650 ↗MalfunctionSep 28, 2022No Flow; Output Problem; No Flow; Output Problem
IT WAS REPORTED THAT THIS HT70 VENTILATOR HAD A BAD BATTERY. 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 15499002 ↗MalfunctionAug 30, 2022No Flow; Power Problem; No Flow; Power Problem
IT WAS REPORTED THAT THE HT70 VENTILATOR WOULD NOT POWER ON. 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 15320351 ↗MalfunctionAug 10, 2022No Flow; Power Problem; No Flow; Power Problem
IT WAS REPORTED THAT THIS HT70 VENTILATOR WOULD NOT POWER ON. 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 15202424 ↗MalfunctionJul 19, 2022No Flow; Power Problem; No Flow; Power Problem
IT WAS REPORTED THAT THE HT70 VENTILATOR WOULD NOT TURN ON. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED E VENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15052861 ↗MalfunctionJul 15, 2022Defective Alarm; Defective Alarm
IT WAS REPORTED THAT THE HT70 VENTILATOR FAILED TO GENERATE AN AUDIBLE ALARM. 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 15032112 ↗MalfunctionJul 12, 2022No Flow; No Flow
IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THIS HT70 VENTILATOR SHUTDOWN. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITHOUT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14993487 ↗
Other VENTILATOR, CONTINUOUS, FACILITY USE devices
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- CARESCAPE R860Datex-Ohmeda Inc · VENTILATOR, CONTINUOUS, FACILITY USE1 recall1 death4,346 reports
- HAMILTON-C1 161001Hamilton Medical AG · Ventilator, Continuous, Facility Use2 recalls12 deaths1,849 reports
- Trilogy Trilogy O2 Ventilator JapanRespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE7 deaths1,900 reports
- Trilogy Trilogy 202 Ventilator InternationalRespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE11 deaths1,564 reports
- HAMILTON-C6 160021Hamilton Medical AG · Ventilator, Continuous, Facility Use5 recalls10 deaths1,175 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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