Newport HT70PM-ES-NA (UDI 10884521542181)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
- 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 10884521542181), received between Jun 4, 2017 and Aug 9, 2017 — 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
- 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
- Insufficient Device Problem Information1
Patient problems
- No Patient Involvement4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 9, 2017Battery Problem; Battery Problem
IT WAS REPORTED THAT AN HT70 PLUS VENTILATOR DISPLAYED BACKUP BATTERY FAILURE AND HAD A COIN BATTERY PROBLEM AFTER TURNING ON THE DEVICE. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT. A SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND REPLACED THE CONTROL BOARD AND COIN BATTERY TO RESOLVE THE ISSUE. THE UNIT PASSED ALL TESTING AND OPERATED WITHIN THE MANUFACTURING SPECIFICATIONS.
Patient problems: No Patient Involvement
MAUDE report 6777845 ↗MalfunctionAug 3, 2017Erratic or Intermittent Display; Erratic or Intermittent Display
IT WAS REPORTED THAT DURING SERVICE THE HT70 PLUS VENTILATOR DISPLAY WAS ERRATIC. THERE WAS NO PATIENT INVOLVEMENT. 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 6764429 ↗MalfunctionAug 1, 2017Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE HT70 PLUS VENTILATOR O2 SENSOR FAILED. THERE WAS NO PATIENT INVOLVEMENT AT THE TIME OF THE 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 6757571 ↗MalfunctionJun 4, 2017Battery Problem; Battery Problem
IT WAS REPORTED THAT THE HT70 VENTILATOR BATTERY DID NOT WORK. THERE WAS NO PATIENT INVOLVEMENT AT THE TIME OF THE REPORTED CONDITION.
Patient problems: No Patient Involvement
MAUDE report 6610363 ↗
Other VENTILATOR, CONTINUOUS, FACILITY USE devices
- Trilogy Trilogy100 Ventilator, United StatesRespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE92 deaths8,161 reports
- Trilogy Evo Trilogy Evo, USARespironics, Inc. · Ventilator, continuous, facility use6 recalls50 deaths4,393 reports
- Trilogy 100 Trilogy 100 W/ Bluetooth, USARespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE65 deaths4,569 reports
- 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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