Newport MXL70A-GR-DSRecalls & reported problems
Covidien LP · LW AIR/O2 MIX W/GRNHS, DISS FT · Class 2
All models of Newport (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521542334), received between Jun 8, 2017 and Jun 16, 2017 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (1 report).
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
Device problems
- Leak/Splash1
- Low Readings1
Patient problems
- No Patient Involvement2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 16, 2017Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE HT70 VENTILATOR BLENDER LEAKED WHEN IT WAS CONNECTED TO THE OXYGEN SOURCE. THERE WAS NO PATIENT INVOLVEMENT AT THE TIME OF THE REPORTED CONDITION. THE CUSTOMER WAS TO BE PROVIDED A REPLACEMENT BLENDER.
Patient problems: No Patient Involvement
MAUDE report 6648851 ↗MalfunctionJun 8, 2017Low Readings; Low Readings
IT WAS REPORTED THAT AFTER INSTALLATION OF A NEW AIR/OXYGEN MIXER THE HT70 VENTILATOR THE OXYGEN WOULD ONLY TO UP TO 70%. THERE WAS NO PATIENT INVOLVEMENT AT THE TIME OF THE REPORTED CONDITION.
Patient problems: No Patient Involvement
MAUDE report 6623405 ↗
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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
- 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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