AcuCare 60786Recalls & reported problems
Resmed Pty Ltd · NV AcuCare F1-0 FFM SML - 5pk · Class 1
- 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 00619498607860), received between Oct 11, 2024 and Oct 11, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component2
Patient problems
- Low Oxygen Saturation2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED TO RESMED THAT THE ELBOW OF AN ACURCARE NON-VENTED F1-0 FULL FACE MASK WITH LOT NUMBER 1445428 DETACHED FROM THE FRAME ASSEMBLY AFTER 30 MINUTES OF USE. PATIENT'S OXYGEN SATURATION DROPPED, MASK WAS REPLACED AND NO FURTHER INTERVENTION WAS REQUIRED.
Patient problems: Low Oxygen Saturation
MAUDE report 20425732 ↗MalfunctionOct 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED TO RESMED THAT THE ELBOW OF AN ACURCARE NON-VENTED F1-0 FULL FACE MASK WITH LOT NUMBER 1445428 DETACHED FROM THE FRAME ASSEMBLY AFTER 30 MINUTES OF USE. PATIENT'S OXYGEN SATURATION DROPPED, MASK WAS REPLACED AND NO FURTHER INTERVENTION WAS REQUIRED.
Patient problems: Low Oxygen Saturation
MAUDE report 20425731 ↗
Other Mask, Oxygen devices
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- HUDSON RCI HUD1930Medline Industries, Inc. · MASK, OXYGEN1 recall12 reports
- Mask, Adult Aerosol, Vented 0250Westmed, Inc. · Mask, Oxygen8 reports
- HUDSON RCI HUD1007Medline Industries, Inc. · MASK, OXYGEN4 reports
- AcuCare 60788Resmed Pty Ltd · Mask, Oxygen4 reports
- Disposable Face Mask 000252956Ambu A/S · MASK, OXYGEN4 reports
- F&P FlexiTrunk BC801-10Fisher & Paykel Healthcare Limited · Mask, Oxygen4 reports
- F&P FlexiTrunk BC802-10Fisher & Paykel Healthcare Limited · Mask, Oxygen2 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.