Allied Medical LLC EPV200Recalls & reported problems
Allied Medical, LLC · Ventilator, Portable W/AC · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00026072000267), received between Dec 1, 2023 and Sep 20, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Circuit Failure” (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.
Reports received per month
Most reported problems
Device problems
- Circuit Failure1
- Gas/Air Leak1
- Inaccurate Delivery1
- Protective Measures Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Low Oxygen Saturation1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 20, 2024Inaccurate Delivery; Inaccurate Delivery
LOW TIDAL VOLUME, BROKEN PRESSURE SWITCH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20273862 ↗MalfunctionSep 20, 2024Gas/Air Leak; Gas/Air Leak
LEAKING PRESSURE INSIDE THE UNIT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20273554 ↗MalfunctionJul 1, 2024Protective Measures Problem; Protective Measures Problem
LOW SOURCE GAS ALARM SOUNDED EVEN WHEN THERE WAS AN ADEQUATE SUPPLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19651267 ↗MalfunctionDec 1, 2023Circuit Failure; Circuit Failure
THE PATIENT WAS CONNECTED TO THE EPV200 WENT INTO DESATURATION AND STARTED HAVING PRBLEMS WITH BREATHING. THE STAFF HAD TO CALL A RAPID RESPONSE TEAM AND A MEDICAL EMERGENCY CODE. DURING THIS INCIDENT IT DID NOT MAKE A SINGLE SOUND.
Patient problems: Low Oxygen Saturation
MAUDE report 18250824 ↗
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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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