Drive MQ5800Recalls & reported problems
Drive Devilbiss Healthcare · Compressor Nebulizer · Class 2
Data updated Oct 16, 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 00822383579153), received between Jul 10, 2020 and Feb 22, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Flare or Flash” (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 16, 2026.
Most reported problems
Device problems
- Flare or Flash1
- Mechanical Problem1
- Smoking1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 22, 2023Smoking; Flare or Flash; Smoking; Flare or Flash
DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A NEBULIZER BY AN END USER, WHO STATED THAT "WHILE I WAS USING IT, IT POPPED, A LITTLE FIRE SHOT OUT AND IT STARTED SMOKING." THERE WAS NO REPORT OR EVIDENCE OF ILLNESS, INJURY OR MEDICAL TREATMENT ASSOCIATED WITH THE COMPLAINT. DRIVE IS CURRENTLY INVESTIGATING THE INCIDENT, INCLUDING ATTEMPTING TO RETRIEVE THE PRODUCT AND INSPECT IT, AND WILL FILE AN UPDATE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16421609 ↗MalfunctionJul 10, 2020Mechanical Problem; Mechanical Problem
THE CUSTOMER REPORTED THAT THE COMPACT COMPRESSOR MQ5800 IS NOT PUSHING OUT AIR TO GET THE MEDICINE TO THE PATIENT. AT THIS TIME, THERE IS NO INFORMATION REGARDING PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10261013 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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