Newport HT70PM-WW-NA (UDI 10884521542266)Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 10884521542266), received between May 7, 2018 and Nov 25, 2019 — classified as 4 deaths, 32 malfunctions.

The most frequently reported specific device problem is “No Flow” (12 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 25 most recent of 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 25, 2019No Flow; No Flow

  IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, AN HT70 VENTILATOR "GENERATED A SYSTEM FAILURE" AND STOPPED VENTILATING. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITH NO HARM OR INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9372548 ↗
• MalfunctionOct 16, 2019Mechanical Problem; Noise, Audible; Mechanical Problem; Noise, Audible

  IT WAS REPORTED THAT DURING THE 12 MONTH CHECK, THE HT70 VENTILATOR PUMP ASSEMBLY WAS GENERATED A NOISE DURING VENTILATION. THERE WAS NO PATIENT INVOLVEMENT AT THE TIME OF THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9198444 ↗
• MalfunctionSep 16, 2019Defective Alarm; Output Problem; Defective Alarm; Output Problem

  CORRECTION: IT WAS OBSERVED THAT DURING SERVICING THE HT70 VENTILATOR FAILED POST (POWER ON SELF-TEST) AND WAS UNABLE TO POWER ON. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9071051 ↗
• MalfunctionAug 2, 2019Erratic or Intermittent Display; Infusion or Flow Problem; Erratic or Intermittent Display; Infusion or Flow Problem

  IT WAS REPORTED THAT THE HT70 VENTILATOR HAD A BLANK DISPLAY. ADDITIONALLY, IT WAS NOTED THAT THE PUMP WAS NOISY. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8857941 ↗
• DeathJul 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPIRED WHILE ON THE HT70 VENTILATOR. THIS EVENT IS BEING CONSERVATIVELY FILED DUE TO THE REPORTED DEATH. AT THIS TIME, THERE IS NO ADDITIONAL INFORMATION AVAILABLE REGARDING THE EVENT OR THE VENTILATOR.

  Patient problems: Death

  MAUDE report 8786243 ↗
• MalfunctionJul 1, 2019Output Problem; Output Problem

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE HT70 PLUS VENTILATOR HAD A MOTOR FAULT ALARM; THE ALARM WAS REPORTED TO BE CONSTANT. THE PATIENT WAS PLACED ON AN ALTERNATE VENTILATOR AND THERE WAS NO HARM TO THE PATIENT AS A RESULT OF THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8748497 ↗
• MalfunctionJun 19, 2019Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT THE HT70 VENTILATOR'S MOTOR PUMP WAS NOISY. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8713483 ↗
• MalfunctionJun 13, 2019Output Problem; Output Problem

  IT WAS REPORTED THAT THE HT70 VENTILATOR WOULD NOT PASS CIRCUIT CHECK. THERE WAS NO PATIENT INVOLVEMENT WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8696717 ↗
• MalfunctionJun 10, 2019Mechanical Problem; No Flow; Mechanical Problem; No Flow

  WHILE SERVICING THE HT70 VENTILATOR, THE VENTILATOR DISPLAYED ¿DATE HAS RESET PLEASE REPLACE COIN BATTERY¿ MESSAGE. IT WAS ADDITIONALLY NOTED THAT THE TOUCHSCREEN WAS UNRESPONSIVE. THE COIN BATTERY WAS REPLACED, AND CIRCUIT CHECK WAS INITIATED. HOWEVER, THE VENTILATOR FAILED THE CIRCUIT CHECK, STOPPED VENTILATING, AND SHUT OFF. THE VENTILATOR POWERED CYCLED ITSELF BUT THEN FROZE ON THE SIX-IMAGE SCREEN. THERE WAS NO PATIENT INVOLVEMENT WITH THE REPORTED EVENT. BASED ON THE PRODUCT ANALYSIS FINDINGS THIS EVENT WAS UPDATED TO REPORTABLE. IF THIS TYPE OF FAULT IDENTIFIED WERE TO OCCUR WHILE IN USE ON A PATIENT IT COULD LEAD TO A LOSS OF VENTILATION.

  Patient problems: No Patient Involvement

  MAUDE report 8683624 ↗
• MalfunctionJun 7, 2019Defective Alarm; Defective Alarm

  IT WAS REPORTED THAT THE HT70 VENTILATOR HAD NO AUDIO ALARM. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8679228 ↗
• MalfunctionApr 18, 2019No Flow; No Flow

  ADDITIONAL INFORMATION RECEIVED AS FOLLOWS: IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE HT70 PLUS VENTILATOR GENERATED AN APNEA ALARM ON THE PATIENT MONITOR. THE MONITOR DISPLAYED NO VENTILATORY PATTERN AND THE PATIENTS PERIPHERAL CAPILLARY OXYGEN SATURATION (SPO2) HAD DECREASED FROM HIGH 90S TO 92 OR SO. IT WAS NOTICED THAT THE PATIENT'S CHEST WAS NOT MOVING. THE UNIT WAS REPORTED TO HAVE STOPPED CYCLING AND QUIT DELIVERING BREATHS. THE VENTILATOR HAD RETURNED TO THE START UP SCREEN WITH THE OPTIONS "START VENTILATION, CIRCUIT CHECK, ACTIVATE PRESET." THE "START VENTILATION" BUTTON WAS SELECTED AND THE VENTILATOR WAS NOTED TO CYCLE AGAIN AND SPO2 QUICKLY RETURNED TO PREVIOUS READINGS AND NO FURTHER ISSUES WERE NOTED. THE PATIENT WAS PLACED ON AN ALTERNATE VENTILATOR SHORTLY AFTER TO BE TAKEN TO THE OPERATING ROOM AND THERE WAS NO HARM TO THE PATIENT, AS A RESULT OF THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8527308 ↗
• MalfunctionApr 15, 2019Defective Alarm; Defective Alarm

  IT WAS REPORTED THAT, DURING USE ON PATIENT, THE HT70 VENTILATOR DID NOT GENERATED AN AUDIO ALARM WHEN THE PATIENT CIRCUIT WAS DISCONNECTED TO USE THE NEBULIZER. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITH NO HARM REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8515986 ↗
• MalfunctionApr 12, 2019No Flow; No Flow

  A RESULT OF THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8511891 ↗
• MalfunctionApr 5, 2019Battery Problem; No Flow; Battery Problem; No Flow

  IT WAS REPORTED THAT DURING USE ON PATIENT THE HT70 VENTILATOR GENERATED A SYSTEM ERROR. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITHOUT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8489294 ↗
• MalfunctionMar 7, 2019Failure to Calibrate; Failure to Calibrate

  IT WAS REPORTED THAT THE HT70 VENTILATOR WAS UNABLE TO CALIBRATE OXYGEN. THERE WAS NO PATIENT INVOLVEMENT WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8401609 ↗
• MalfunctionMar 6, 2019No Flow; No Flow

  IT WAS REPORTED THAT DURING USE ON PATIENT THE HT70 VENTILATOR EXPERIENCED A SYSTEM ERROR WITH A CONSTANT ALARM AND VENTILATION STOP PED. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITHOUT HARM OR INJURY.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 8395390 ↗
• DeathFeb 21, 2019Use of Incorrect Control/Treatment Settings; Improper or Incorrect Procedure or Method; Use of Incorrect Control/Treatment Settings; Improper or Incorrect Procedure or Method

  IT WAS REPORTED DURING USE ON A PATIENT WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (CARBON DIOXIDE RETAINER), THE HT70 VENTILATOR WAS AUTO CYCLING AND HAD A HIGH RESPIRATORY RATE WITH NO AUDIO ALARM GENERATED. THE PATIENT WAS FOUND DECANNULATED WITH THE TRACH OUT. AFTER THE EVENT, THE PATIENT WAS FOUND TO BE DECEASED. UPON EVALUATING THE DEVICE, THE SERVICE ENGINEER FOUND THAT THE CUSTOMER HAD SET THE ALARM LIMITS TO THE MAXIMUM AND MINIMUM LIMITS, WHICH IS OUT OF RANGE TO DETECT ANY PATIENT READINGS. THIS REPORT IS BEING CONSERVATIVELY FILED DUE TO USE ERROR AND PATIENT DEATH. THERE WAS NO MALFUNCTION OR PRODUCT DEFICIENCY ASSOCIATED WITH THE VENTILATOR.

  Patient problems: Death

  MAUDE report 8359245 ↗
• MalfunctionDec 17, 2018No Flow; No Flow

  IT WAS REPORTED THAT DURING USE ON PATIENT THE HT70 VENTILATOR HAD FROZEN SCREEN AND OBSERVED THAT THE DEVICE STOPPED DELIVERING VEN TILATION. PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITH NO HARM REPORTED.

  Patient problems: No Code Available

  MAUDE report 8170042 ↗
• MalfunctionDec 17, 2018Defective Alarm; Defective Alarm

  THE BIOMEDICAL ENGINEER REPORTED THAT PRIOR TO USE THE HT70 VENTILATOR DOWN ARROW KEY WAS NOT FUNCTIONING. ADDITIONALLY, THE SERVICE ENGINEER EVALUATED THE DEVICE AND FOUND THE DEVICE HAD NO AUDIBLE ALARM. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8169856 ↗
• MalfunctionOct 22, 2018No Flow; No Flow

  IT WAS REPORTED THAT DURING USE ON A PATIENT, HT70 VENTILATOR STOPPED VENTILATING. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Code Available

  MAUDE report 7993402 ↗
• MalfunctionSep 7, 2018Defective Alarm; Defective Alarm

  IT WAS REPORTED THAT THE HT70 VENTILATOR DOWN ARROW KEY WAS NOT WORKING AND ADDITIONALLY FOUND ALARM SILENCE LIGHT-EMITTING DIODE (LED) WOULD COME ON AUTOMATICALLY. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7856619 ↗
• MalfunctionSep 7, 2018Defective Alarm; Defective Alarm

  IT WAS REPORTED THAT THE HT70 VENTILATOR DOWN ARROW KEY WAS NOT WORKING AND ADDITIONALLY FOUND ALARM SILENCE LIGHT-EMITTING DIODE (LED) WOULD COME ON AUTOMATICALLY. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7856456 ↗
• MalfunctionAug 29, 2018No Flow; No Flow

  IT WAS REPORTED THAT DURING USE ON A PATIENT THE HT70 VENTILATOR HAD GENERATED SYSTEM ERROR AND STOPPED VENTILATION. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITH NO HARM REPORTED.

  Patient problems: No Code Available

  MAUDE report 7828197 ↗
• MalfunctionAug 24, 2018Failure to Pump; Failure to Pump

  IT WAS REPORTED THAT THE HT70 VENTILATOR HAD MOTOR PUMP FAILURE. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7813666 ↗
• MalfunctionAug 15, 2018Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT DURING THE 12 MONTH CHECK, THE HT70 VENTILATOR PUMP ASSEMBLY WAS GENERATING NOISE DURING VENTILATION. THERE WAS NO PATIENT INVOLVEMENT AT THE TIME OF THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7787416 ↗