Philips Home Nebulizer 1130530Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 06946159503020), received between Nov 20, 2023 and May 9, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Smoking” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K031413); 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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 9, 2025Failure to Deliver; Failure to Deliver

  THE MANUFACTURER RECEIVED INFORMATION FROM A USER OF A PHILIPS HOME NEBULIZER DEVICE ALLEGING THE DEVICE IS NOT WORKING AND WOULD LIKE A REPLACEMENT. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21998899 ↗
• MalfunctionMay 3, 2024Fire; Smoking; Fire; Smoking

  THE MANUFACTURER BECAME AWARE OF ALLEGATIONS THAT A HOME NEB 120V60HZ CATCHING FIRE AND SENDING SMOKE OUT THE HOSE AND "SPRAYED" WHITE SMOKE AROUND THE ROOM DURING USE. IN ADDITION, THE PATIENT REPORTED DEVICE CONTINUED SMOKING LONG AFTER THE FIRE WAS PUT OUT. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19236005 ↗
• MalfunctionNov 20, 2023Smoking; Smoking

  THE MANUFACTURER BECAME AWARE OF ALLEGATIONS THAT A HOME NEB 120V60HZ SHOWING SMOKE FROM THE DEVICE. IN ADDITION, THE PATIENT REPORTED SMELL POSSIBLY DUE TO OVERHEATING OF THE DEVICE. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18171115 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K031413. One submission often covers many models, so check the product and lot details in each record.

• Z-1720-2015 · Apr 20, 2015 · Terminated
  Roscoe Mini Neb Compressor User Manual for the NEB-ROS Product Usage: Inhaler therapy that converts liquid medicine into a fine mist that is easily inhaled.