Newport HT70PM-JP-NA (UDI 10884521544321)Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 10884521544321), received between Sep 5, 2019 and Apr 29, 2026 — classified as 1 death, 45 malfunctions.

The most frequently reported specific device problem is “No Flow” (32 reports).

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.

Most reported problems

Recent adverse event reports

The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2026Defective Alarm

  IT WAS REPORTED THAT DURING SERVICING PERFORMED BY MEDTRONIC, THE HT70 VENTILATOR WAS OBSERVED TO NOT PASS THE SHUTDOWN BUZZER ALARM TEST. 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 25037963 ↗
• MalfunctionFeb 12, 2026Defective Alarm; Output Problem

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE HT70 VENTILATOR GENERATED AN OXYGEN (O2) CONCENTRATION ALARM. THE VENTILATOR WAS CONTINUED TO BE USED ON THE PATIENT WITHOUT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24327370 ↗
• MalfunctionDec 9, 2025No Flow; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE VENTILATION STOPPED ON HIS HT70 VENTILATOR WITH A CONSTANT ALARM SOUNDED. 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 23762880 ↗
• MalfunctionAug 13, 2025No Flow; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE VENTILATION STOPPED ON THIS HT70 VENTILATOR, THE SCREEN DISAPPEARED AND A CONTINUOUS ALARM SOUND OCCURRED. 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 22797815 ↗
• MalfunctionAug 12, 2025No Flow; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE HT70 VENTILATOR GENERATED A CONTINUOUS ALARM SOUND, THE SCREEN WENT COMPLETELY BLACK AND THE UNIT SHUTDOWN. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND WAS PLACED IN AN ALTERNATE VENTILATOR WITHOUT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22786739 ↗
• MalfunctionJul 25, 2025Defective Alarm; Defective Alarm

  IT WAS REPORTED THAT THE ALARM RELATED TO THE CAPACITOR OF THIS HT70 VENTILATOR, WHICH WAS SUPPOSED TO ACTIVATE WHEN TURNING HE POWER ON AND OFF, DID NOT SOUND. 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 22616881 ↗
• MalfunctionJul 9, 2025No Flow; Power Problem; No Flow; Power Problem

  IT WAS REPORTED THAT DURING SERVICING, THE HT70 VENTILATOR WAS OBSERVED TO SUDDENLY SHUT DOWN FROM STANDBY MODE. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT. REPORTABILITY REASSESSED BASED ON THE PRODUCT ANALYSIS FINDINGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22461358 ↗
• MalfunctionJun 26, 2025Defective Alarm; Defective Alarm

  IT WAS REPORTED THAT THE HT70 VENTILATOR GENERATED A BACKGROUND CHECK ALERT "ASSERT ERROR" MESSAGE AND THE UNIT'S ALARM SOUNDED FOR A MOMENT, THEN THE DEVICE SILENCED ON ITS OWN WHEN THE POWER WAS SWITCHED 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 22337659 ↗
• MalfunctionJun 6, 2025Defective Alarm; Defective Alarm

  IT WAS REPORTED THAT DURING PREVENTATIVE MAINTENANCE (PM) PERFORMED BY THE MEDTRONIC PERSONNEL, THIS HT70 VENTILATOR WAS OBSERVED TO HAVE FAILED THE SHUTDOWN BUZZER ALARM TEST. 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 22161638 ↗
• MalfunctionJun 6, 2025Defective Alarm; Defective Alarm

  IT WAS REPORTED THAT DURING SERVICING, THE ALARM GENERATED BY THIS HT70 VENTILATOR AFTER SHUTTING DOWN WAS NOTED TO HAVE AN "ABNORMAL" SOUND. 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 22161487 ↗
• MalfunctionJun 6, 2025Defective Alarm; Infusion or Flow Problem; Defective Alarm; Infusion or Flow Problem

  IT WAS REPORTED THAT DURING SERVICING BY MEDTRONIC SERVICE PERSONNEL, THE PUMP OF THIS HT70 VENTILATOR WAS NOTED TO HAVE A LEAK, THE POSITIVE END EXPIRATORY PRESSURE (PEEP) WAS FOUND TO BE UNSTABLE AND THE CONTROL BOARD  SHUTDOWN BUZZER WAS NOTED TO HAVE A FAILURE. 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 22160981 ↗
• MalfunctionApr 16, 2025No Flow; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE HT70 VENTILATOR GENERATED A CONTINUOUS ALARM AND THE VENTILATION STOPPED. THE OXYGEN (O2) SATURATION OF THE PATIENT TEMPORARILY DECREASED TO 89%. THE PATIENT WAS MANUALLY VENTILATED AND TRANSFERRED TO AN ALTERNATE VENTILATOR WITHOUT INJURY. THE PATIENT RECOVERED FROM THE O2 SATURATION DROP WITHIN TWO MINUTES.

  Patient problems: Low Oxygen Saturation

  MAUDE report 21848672 ↗
• DeathFeb 12, 2025No Flow; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON AN ELDERLY, TERMINALLY ILL PATIENT, THE HT70 VENTILATOR GENERATED AN ALARM AND VENTILATION STOPPED. WHILE BEING TRANSFERRED TO AN ALTERNATE VENTILATOR, THE PATIENT EXPERIENCED CARDIAC ARREST AND CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED, BUT THE PATIENT DID NOT SURVIVE.

  Patient problems: Respiratory Failure

  MAUDE report 21368834 ↗
• MalfunctionDec 12, 2024No Flow; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT AT HOME, THIS HT70 VENTILATOR GENERATED A "SYSTEM ERROR" AND THE VENTILATION STOPPED. A CONTINUOUS ALARM WAS GENERATED AND THE POWER WAS UNABLE TO BE TURNED OFF. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20919294 ↗
• MalfunctionAug 14, 2024No Flow; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THIS HT70 VENTILATOR HAD A SYSTEM ERROR, THE LIQUID CRYSTAL DISPLAY (LCD) BECAME DARK, AND VENTILATION STOPPED. 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 19983957 ↗
• MalfunctionJun 26, 2024No Flow; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THIS HT70 VENTILATOR HAD A SYSTEM ERROR. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19615209 ↗
• MalfunctionJun 20, 2024No Flow; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE HT70 VENTILATOR GENERATED A SHUTDOWN ALARM AND VENTILATION STOPPED. 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 19578385 ↗
• MalfunctionJun 18, 2024No Flow; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THIS HT70 VENTILATOR GENERATED A BEEPING ALARM SOUNDS AND A SYSTEM ERROR WAS DISPLAYED. 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 19564070 ↗
• MalfunctionMay 8, 2024Defective Alarm; No Flow; Defective Alarm; No Flow

  ADDITIONAL INFORMATION RECEIVED AS FOLLOWS: IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THIS HT70 VENTILATOR DID NOT ALARM, SHUTDOWN AND VENTILATION STOPPED. THE PATIENT WAS PLACED ON AN ALTERNATE VENTILATOR WITHOUT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19274868 ↗
• MalfunctionApr 22, 2024No Flow; No Flow

  IT WAS REPORTED THAT VENTILATION STOPPED WHILE THIS HT70 VENTILATOR WAS IN USE ON A PATIENT. THE PATIENT'S PERIPHERAL CAPILLARY OXYGEN SATURATION (SPO2) LEVEL DROPPED TO 50% AND THEN IMPROVED AFTER PLACING THE PATIENT ON AN ALTERNATE VENTILATOR.

  Patient problems: Low Oxygen Saturation

  MAUDE report 19153662 ↗
• MalfunctionApr 11, 2024Device Sensing Problem; No Flow; Power Problem; Device Sensing Problem; No Flow; Power Problem

  IT WAS REPORTED THAT WHILE VENTILATING ON THE TEST LUNG, THE HT70 VENTILATOR GENERATED AN ALARM AND THE POWER WAS FOUND TO HAVE SHUT DOWN. ADDITIONALLY, THE MUTE AND RESTART BUTTONS WERE NOT WORKING. 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 19093637 ↗
• MalfunctionDec 8, 2023No Flow; No Flow

  IT WAS REPORTED THAT THE HT70 VENTILATOR GENERATED A SYSTEM ERROR AND VENTILATION STOPPED WHILE THE PATIENT WAS CONNECTED. THE OXYGEN SATURATION OF THE PATIENT DROPPED TO 91% AND HEART RATE WAS 131 BPM. ADDITIONALLY, THE ALARM COULD NOT BE SILENCED AND THE POWER COULD NOT BE TURNED OFF. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND WAS PLACED ON AN ALTERNATE VENTILATOR WITHOUT INJURY.

  Patient problems: Low Oxygen Saturation; Tachycardia

  MAUDE report 18293937 ↗
• MalfunctionOct 9, 2023No Flow; No Flow

  IT WAS REPORTED THAT THE HT70 VENTILATOR GENERATED A CONTINUOUS BEEPING SOUND, THE DISPLAY ON THE MONITOR DISAPPEARED AND THE VENTILATION STOPPED WHILE THE PATIENT WAS CONNECTED. 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 17898016 ↗
• MalfunctionAug 18, 2023No Flow; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THIS HT70 VENTILATOR HAD A BLACK SCREEN, GENERATED AN ALARM AND VENTILATION STOPPED THEN SHUTDOWN. THE PATIENT WAS PLACED ON AN ALTERNATE VENTILATOR WITHOUT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17577476 ↗
• MalfunctionJul 31, 2023Defective Alarm; Defective Alarm

  IT WAS REPORTED THAT DURING SERVICING, THE SHUTDOWN BUZZER ALARM OF THIS HT70 VENTILATOR DID NOT SOUND. 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 17426537 ↗