DRIVEMEDICAL 18070Recalls & reported problems
Drive Devilbiss Healthcare · RespiratoryNebs Product Description: Pacifica Elite Nebulizer,6RTL/CS, 6/cv · Class 2
All models of DRIVEMEDICAL (111)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00822383264851), received between Aug 10, 2016 and Aug 10, 2016 — classified as 1 injury.
The most frequently reported specific device problem is “No Flow” (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
- No Flow1
Patient problems
- Insufficient Information1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 10, 2016No Flow; No Flow
(B)(4) RECEIVED NOTIFICATION OF AN INCIDENT FROM A PATIENT USING A NEBULIZER THAT (B)(4) IMPORTS AND DISTRIBUTES. THE END USER WAS USING THE NEBULIZER (18070) ALLEGEDLY WHEN THE MOTOR BECAME INCREASINGLY LOUDER AND STARTED VIBRATING. SHE POWERED THE NEBULIZER ON/OFF AND NO AIR FLOW WAS BEING PRODUCED. SHE WAS TAKEN TO (B)(6) HOSPITAL WHERE SHE STAYED FOR 2 DAYS. THE END USER STATED SHE IS FINE NOW BUT, WOULD LIKE A REPLACEMENT UNIT.
Patient problems: Insufficient Information; No Consequences Or Impact To Patient
MAUDE report 5866759 ↗
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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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