Newport HT70PM-SY-EU (UDI 10884521544369)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.

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

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521544369), received between Aug 11, 2017 and Aug 11, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Defective Alarm” (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

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

Defective Alarm1
No Display/Image1
No Flow1

Patient problems

Coma1
No Information1

Recent adverse event reports

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

InjuryAug 11, 2023Defective Alarm; No Flow; Defective Alarm; No Flow
IT WAS REPORTED THAT WHILE IN USE ON A HOME CARE PATIENT, THIS HT70 VENTILATOR SUDDENLY STOPPED WORKING AND THERE WAS NO ALARM OR CODES GENERATED. THE PATIENT TURNED BLUE, AND WAS UNCONSCIOUS AFTERWARDS. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND MANUALLY VENTILATED VIA AN AMBU BAG. WHEN THE AMBULANCE ARRIVED, THE PATIENT'S OXYGEN (O2) SATURATION WAS AT 50 %, AND THE END-TIDAL CARBON DIOXIDE (ETCO2) WAS AT 80 MMHG. THE PATIENT WAS PLACED ON AN ALTERNATE VENTILATOR AND THE O2 SATURATION AND CARBON DIOXIDE (CO2) IMPROVED BUT THE PATIENT REMAINED UNRESPONSIVE. THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO DROP IN GLASGOW COMA SCALE.
Patient problems: Coma
MAUDE report 17514570 ↗
MalfunctionAug 11, 2017No Display/Image; No Display/Image
IT WAS REPORTED THAT THE HT70 PLUS VENTILATOR HAD BLANK SCREEN. PATIENT INVOLVEMENT WAS NOT REPORTED. 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 6789169 ↗

Device details

UDI-DI	`10884521544369`
Brand	Newport
Model	HT70PM-SY-EU
Company	Newport Medical Instruments, Inc.
Product code	CBK · VENTILATOR, CONTINUOUS, FACILITY USE
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	OTC
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Mar 15, 2024

Device type (GMDN): Neonatal/adult intensive-care ventilator

A mains electricity (AC-powered) automatic cycling device intended to provide long-term alveolar ventilation support for the full age-range of patients, from neonatal, paediatric to adult, in a critical care setting. It typically uses positive pressure to deliver gas at normal breathing rates and tidal volumes through an endotracheal (ET) tube or tracheostomy, and consists of a breathing circuit, a control system, monitors, and alarms. The inhalation limb includes sites where inspired gas may be heated/humidified, and the exhalation limb includes an exhaust valve to release gas to the ambient air. It can be operated in several modes (e.g., assist/control, synchronized, patient triggered).

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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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