Newport HT70M-WW-NA (UDI 10884521542143)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10884521542143), received between Jul 13, 2017 and Mar 19, 2022 — classified as 1 death, 8 malfunctions.

The most frequently reported specific device problem is “Alarm Not Visible” (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

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2022No Flow; No Flow

  IT WAS REPORTED THAT THIS HT70 VENTILATOR STOPPED WORKING WHILE THE PATIENT WAS SLEEPING. THE PATIENT WAS TRANSFERRED TO A BACKUP VENTILATOR WITHOUT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13827966 ↗
• MalfunctionAug 2, 2019Device Alarm System; Device Sensing Problem; Device Alarm System; Device Sensing Problem

  IT WAS REPORTED THAT THE HT70 VENTILATOR DOWN ARROW WAS NOT RESPONDING AND THAT THE AUDIBLE ALARMS WERE NOT SOUNDING PROPERLY. THE ALARM WAS REPORTED TO SOUND BUT WAS "INCOMPLETE IT SPUTTERED". THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE EVENT. DURING EVALUATION, THE HT70 VENTILATOR FAILED TO ALARM ON SHUTDOWN.

  Patient problems: No Patient Involvement

  MAUDE report 8854914 ↗
• MalfunctionOct 2, 2018Defective Alarm; Defective Alarm

  IT WAS REPORTED THAT THE HT70 VENTILATOR HAD A CRACKED CASE AND HANDLE. THERE WAS NO PATIENT INVOLVEMENT WITH THE REPORTED EVENT. UPON RECEIVING THE DEVICE FOR EVALUATION, IT WAS OBSERVED THAT THE SILENCE BUTTON LIGHT WAS FLASHING INTERMITTENTLY AND CAUSED NO AUDIBLE ALARM WHEN THE UNIT WAS TURNED OFF.

  Patient problems: No Patient Involvement

  MAUDE report 7926227 ↗
• MalfunctionAug 22, 2018Defective Alarm; Defective Alarm

  IT WAS REPORTED THAT THE HT70 VENTILATOR HAD NOT GENERATED AN AUDIBLE ALARM WHEN THE DEVICE WAS SHUT DOWN. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7806608 ↗
• DeathJul 17, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPIRED WHILE ON HT70 VENTILATOR. THERE IS NO ALLEGATION OF A MALFUNCTION OF THE DEVICE. THE CUSTOMER IS SENDING THE VENTILATOR FOR FAILURE EVALUATION. THIS REPORT IS BEING CONSERVATIVELY FILED ONLY BECAUSE THE PATIENT EXPIRED WHILE USING THE VENTILATOR.

  Patient problems: Death

  MAUDE report 7696592 ↗
• MalfunctionMay 22, 2018No Audible Alarm; Alarm Not Visible; No Audible Alarm; Alarm Not Visible

  IT WAS REPORTED THAT THE HT70 VENTILATOR HAD A BROKEN CASE AND WAS BEING SENT BACK FOR PREVENTATIVE MAINTENANCE (PM). THE BUZZER ALARM WAS WORKING AT THE TIME OF THE ESTIMATE TO THE CUSTOMER. AFTER THE REPAIR WERE PERFORMED THE SERVICE THE ENGINEER CHECKED THE VENTILATOR AND FOUND THAT THE BUZZER WAS NOT ALARMING WHEN THE UNIT WAS TURNED OFF. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7535246 ↗
• MalfunctionApr 24, 2018No Audible Alarm; Alarm Not Visible; No Audible Alarm; Alarm Not Visible

  IT WAS REPORTED THAT THE HT70 VENTILATOR EXPERIENCED A SYSTEM ERROR AND DEVICE ALERT WITH NO AUDIBLE OR VISUAL ALARMS. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7457178 ↗
• MalfunctionAug 10, 2017Failure to Calibrate; Failure to Calibrate

  IT WAS REPORTED THAT THE HT70 VENTILATOR FAILED OXYGEN (O2) SENSOR CALIBRATION. 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 6786280 ↗
• MalfunctionJul 13, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT THE HT70 VENTILATOR HAD O2 SENSOR ERROR. PATIENT INVOLVEMENT IS UNKNOWN. 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 6711331 ↗