Newport HT70PM-SY-EU (UDI 10884521542228)Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10884521542228), received between Mar 31, 2017 and Sep 20, 2023 — classified as 1 injury, 22 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (10 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 20, 2023No Flow; No Flow

  UPDATED: IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THIS HT70 VENTILATOR WOULD EXPERIENCE LOW PRESSURE AND RANDOMLY TURNED OFF DURING VENTILATION. ALTHOUGH REQUESTED, PATIENT OUTCOME AND INTERVENTION ARE UNKNOWN AT THIS TIME. ALTHOUGH IT WAS REPORTED THAT THE VENTILATOR RANDOMLY TURNED OFF DURING VENTILATION, BASED ON THE REVIEW OF THE LOGS, THERE'S NO EVIDENCE OF MALFUNCTION THAT WOULD LEAD TO LOSS OF VENTILATION. THE LOGS SHOW THAT THE CUSTOMER WAS ACTIVELY POWERING THE DEVICE OFF.

  Patient problems: Insufficient Information

  MAUDE report 17785292 ↗
• MalfunctionDec 13, 2019No Flow; Power Problem; No Flow; Power Problem

  RECEIVED CLARIFICATION FROM THE INITIAL REPORTER STATING THAT THE REPORTED EVENT OCCURRED DURING DEMONSTRATION OF THE HT70 VENTILATOR AND THERE WAS NO PATIENT INVOLVEMENT AT THE TIME OF REPORTED EVENT.

  Patient problems: No Information; No Patient Involvement

  MAUDE report 9470041 ↗
• MalfunctionAug 14, 2017Failure to Pump; Failure to Pump

  IT WAS REPORTED THAT DURING PREVENTATIVE MAINTENANCE, THE HT70 PLUS VENTILATOR PUMP WAS NOT WORKING PROPERLY. THERE WAS NO PATIENT INVOLVEMENT AT THE TIME OF THE EVENT. THE SERVICE ENGINEER EVALUATED THE VENTILATOR AND REPLACED THE PUMP AND MANIFOLD ASSEMBLY. THE VENTILATOR PASSED ALL TESTING.

  Patient problems: No Information; No Patient Involvement

  MAUDE report 6792072 ↗
• MalfunctionAug 11, 2017Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT AN HT70 PLUS VENTILATOR HAD FROZEN SCREEN. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT. A SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND FOUND THAT THE SINGLE BOARD COMPUTER (SBC) BOARD NEEDED TO BE REPLACED.

  Patient problems: No Patient Involvement

  MAUDE report 6789988 ↗
• InjuryAug 10, 2017Loss of Power; Loss of Power

  IT WAS REPORTED THAT THE HT70 PLUS VENTILATOR HAD NO POWER DURING PATIENT VENTILATION. THERE WAS NO INJURY OR HARM TO THE PATIENT.

  Patient problems: No Information

  MAUDE report 6786433 ↗
• MalfunctionAug 10, 2017Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE HT70 PLUS VENTILATOR HAD A COIN BATTERY FAILURE. ALTHOUGH REQUESTED, INFORMATION PERTAINING TO THE USE OF THE DEVICE AT THE TIME OF THE REPORTED EVENT AND PATIENT OUTCOME (IF APPLICABLE) HAS NOT BEEN PROVIDED. 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; No Patient Involvement

  MAUDE report 6785388 ↗
• MalfunctionAug 10, 2017Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE HT70 PLUS VENTILATOR HAD A COIN BATTERY FAILURE. 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 6785334 ↗
• MalfunctionAug 10, 2017Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE HT70 PLUS VENTILATOR HAD A COIN BATTERY ISSUE. 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 WAS COMPLETED AT A NON-MEDTRONIC LOCATION. THE SERVICE PROVIDER INSPECTED THE DEVICE AND REPLACED THE COIN BATTERY AND THE UNIT PASSED ALL TESTING. 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 6785329 ↗
• MalfunctionAug 10, 2017Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE HT70 PLUS VENTILATOR HAD A COIN BATTERY ISSUE. 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 6785271 ↗
• MalfunctionAug 10, 2017Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED DURING SERVICE, THE HT70 PLUS VENTILATOR HAD A TOUCH PANEL FAILURE. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 6785231 ↗
• MalfunctionAug 10, 2017Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE HT70 PLUS VENTILATOR HAD A COIN BATTERY ISSUE. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 6785056 ↗
• MalfunctionAug 10, 2017Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE HT70 PLUS VENTILATOR HAD COIN BATTERY ISSUE. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 6785027 ↗
• MalfunctionJul 31, 2017Battery Problem; Battery Problem

  IT WAS REPORTED THAT DURING MAINTENANCE HT70 PLUS VENTILATOR COIN BATTERY, POWER PAC BATTERY AND INTERNAL BATTERY WERE DEPLETED. THERE WAS NO PATIENT INVOLVEMENT. THE SERVICE ENGINEER REPLACED THE COIN BATTERY, INTERNAL BACKUP BATTERY AND POWER PACK BATTERY. THE UNIT PASSED ALL TESTING AND OPERATES WITHIN THE MANUFACTURING SPECIFICATIONS.

  Patient problems: No Patient Involvement

  MAUDE report 6754181 ↗
• MalfunctionJun 7, 2017Battery Problem; Battery Problem

  THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Information; No Patient Involvement

  MAUDE report 6619858 ↗
• MalfunctionJun 7, 2017Leak/Splash; Noise, Audible; Leak/Splash; Noise, Audible

  IT WAS REPORTED THAT THE HT70 VENTILATOR GENERATED A LEAKING NOISE FROM THE OXYGEN REDUCER. THERE WAS NO PATIENT INVOLVEMENT AT THE TIME OF THE REPORTED CONDITION.

  Patient problems: No Patient Involvement

  MAUDE report 6618464 ↗
• MalfunctionJun 6, 2017Battery Problem; Battery Problem

  THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Information; No Patient Involvement

  MAUDE report 6616410 ↗
• MalfunctionJun 2, 2017No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE HT70 VENTILATOR SCREEN FROZE DURING POWER ON SELF TEST ( POST). THERE WAS NO PATIENT INVOLVEMENT REPORTED. COVIDIEN WAS NOT AUTHORIZED TO SERVICE THE DEVICE. A THIRD PARTY SERVICE CENTER ADDRESSED THE ISSUE BY REPLACING THE SINGLE-BOARD COMPUTER (SBC) BOARD WAS REPLACED. THE VENTILATOR WAS REPORTED TO BE RUNNING NORMALLY.

  Patient problems: No Patient Involvement

  MAUDE report 6608531 ↗
• MalfunctionJun 2, 2017Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT, BEFORE INSTALLING IN HOSPITAL (CUSTOMER SITE), WHILE DOING OPERATIONAL TEST, THE HT70 GENERATED AN ABNORMAL NOISE THERE WAS NO PATIENT INVOLVEMENT AT THE TIME OF THE REPORTED CONDITION.

  Patient problems: No Patient Involvement

  MAUDE report 6607890 ↗
• MalfunctionMay 19, 2017No Display/Image; No Display/Image

  IT WAS REPORTED THAT AFTER CONNECTING THE POWER CABLE TO THE HT70 VENTILATOR, THE ALARM SOUNDS WHEN THE POWER IS TURNED OFF. SERVICE ENGINEER EVALUATED THE DEVICE, FOUND THE MAIN PRINTED CIRCUIT BOARD (PCB) WAS FAULTY, REPLACED THE MAIN PCB AND THE VENTILATOR WORKED PROPERLY. THIS WAS A FAILURE OUT OF BOX (FOOB). THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 6580016 ↗
• MalfunctionMay 19, 2017No Display/Image; No Display/Image

  MEDTRONIC RECEIVED INFORMATION STATING DURING SET UP THE HT70 VENTILATOR CANNOT COMPLETE THE BOOT UP PROCESS. THE DISPLAY FROZE AND THE VENTILATOR WAS UNABLE TO SHUT OFF. THE MACHINE COULD ONLY BE SHUT OFF AFTER THE BATTERY WAS EMPTY. THE SOFTWARE WAS UPGRADED BUT IT DID NOT RESOLVE THE ISSUE. THE SINGLE BOARD COMPUTER NEEDS TO BE REPLACED. THIS WAS A FAILURE OUT OF BOX (FOOB). THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 6579582 ↗
• MalfunctionMay 9, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A HT70 VENTILATOR HAD AN OXYGEN MIXER LEAK. THE CUSTOMER DID NOT PROVIDE PATIENT INVOLVEMENT INFORMATION. A MEDTRONIC FIELD SERVICE ENGINEER (FSE) EVALUATED THE VENTILATOR AND CONFIRMED THE CUSTOMER REPORTED ISSUE. IT WAS DETERMINED THAT THE OXYGEN MIXER NEEDS TO BE REPLACED.

  Patient problems: No Information

  MAUDE report 6555033 ↗
• MalfunctionMay 8, 2017Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE HT70 PLUS VENTILATOR WAS UNABLE TO LOAD HARDWARE ON THE LOADING SCREEN AND THE COIN BATTERY NEEDED TO BE REPLACED. THE VENTILATOR WAS NOT ON A PATIENT AT THE TIME OF THE EVENT. THE MEDTRONIC FIELD SERVICE ENGINEER (FSE) EVALUATED THE VENTILATOR AND CONFIRMED THE CUSTOMER REPORTED ISSUE. THE COIN BATTERY WAS REPLACED, WHICH RESOLVED THE ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 6552204 ↗
• MalfunctionMar 31, 2017No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE HT70 PLUS VENTILATOR TOUCH SCREEN WAS NOT WORKING. PATIENT INVOLVEMENT IS UNKNOWN.

  Patient problems: No Information

  MAUDE report 6449826 ↗