Sunset Compressor Nebulizer w/ Disposable Adult Neb Kit NEB100Recalls & reported problems
Sunset Healthcare Solutions, Inc. · Sunset Compressor Nebulizer w/ Disposable Adult Neb Kit · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00848530087326), received between Jan 29, 2019 and Jan 2, 2020 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Failure to Power Up” (1 report).
1 other recall cover devices cleared under the same FDA submission (K091272); they may or may not involve this specific model.
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
- Failure to Power Up1
- Improper or Incorrect Procedure or Method1
Patient problems
- Asthma1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 2, 2020Failure to Power Up; Failure to Power Up
THE END USER REPORTED THE COMPRESSOR NEBULIZER (NEB100) WOULD NOT POWER ON RIGHT OUT OF THE BOX DURING AN ASTHMA ATTACK. END USER REPORTS GOING TO THE EMERGENCY ROOM FOR TREATMENT.
Patient problems: Asthma
MAUDE report 9541238 ↗MalfunctionJan 29, 2019Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
THE SUNSET COMPRESSOR NEBULIZER, NEB100, CLEARED FOR USE IN THE U.S. WAS SOLD BY A THIRD-PARTY DISTRIBUTOR IN (B)(4) WHERE THE VOLTAGE IS 220V. THIS DEVICE NEB100 DEVICE IS DESIGNED FOR THE U.S. MARKET, WITH A VOLTAGE REQUIREMENT OF 120V. WHEN THE DEVICE WAS USED OUTSIDE OF ITS SPECIFIED VOLTAGE, THE MOTOR OVERHEATED AND STOPPED FUNCTIONING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8286974 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K091272. One submission often covers many models, so check the product and lot details in each record.
- Z-1058-2019 · Aug 29, 2018 · TerminatedSunset Compressor Nebulizer, Model NEB100 - Product Usage: The Sunset Compressor Nebulizer is an AC-powered air nebulizer compressor system intended to provide a source of compress
Other Nebulizer (Direct Patient Interface) devices
- HUDSON RCI IPN049807Teleflex Incorporated · NEBULIZER (DIRECT PATIENT INTERFACE)62 reports
- Circulaire™ 0330Sunmed, LLC · Nebulizer (Direct Patient Interface)1 recall0 reports
- I neb 00Respironics Respiratory Drug Delivery (Uk) Ltd · NEBULIZER (DIRECT PATIENT INTERFACE)3 deaths15 reports
- VixOne 0209Westmed, Inc. · Nebulizer (Direct Patient Interface)13 reports
- HUDSON RCI IPN040620Teleflex Incorporated · NEBULIZER (DIRECT PATIENT INTERFACE)12 reports
- HUDSON RCI IPN049808Teleflex Incorporated · NEBULIZER (DIRECT PATIENT INTERFACE)6 reports
- HUDSON RCI HUD05014Medline Industries, Inc. · Nebulizer (direct patient interface)6 reports
- VixOne 0210Westmed, Inc. · Nebulizer (Direct Patient Interface)5 reports
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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