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DeVilbiss 3655LTRecalls & reported problems

Devilbiss Healthcare LLC · Compressor / Nebulizer with disposable · Class 2

Adverse event reports
1
Deaths reported
1
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885304001782), received between Aug 31, 2021 and Aug 31, 2021 — classified as 1 death.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Insufficient Information1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • DeathAug 31, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    DEVILBISS HEALTHCARE BECAME AWARE OF THE INCIDENT FROM A COMMUNICATION BY THE SERVICE PROVIDER. THE PATIENT'S GIRLFRIENDS NOTIFIED THE SERVICE PROVIDER'S BILLING DEPARTMENT OF PATIENT'S DEATH. SERVICE PROVIDER'S STAFF VISITED THE RESIDENCE AND FOUND HOME DAMAGED BY FIRE. PATIENT'S GIRLFRIEND STATED THAT HIS DEATH WAS UNRELATED TO THE FIRE. WE HAVE RECEIVED THE FIRE REPORT NOTING SUSPECTED ARSON. THERE WERE MULTIPLE FIRES IN THE DWELLING FUELED BY STACKED FURNISHINGS. WE HAVE NOT RECEIVED THE DEVICE FOR EVALUATION. SINCE IT WAS LOST IN THE FIRE.

    Patient problems: Insufficient Information

    MAUDE report 12394330 ↗

Other Nebulizer (Direct Patient Interface) devices

All Nebulizer (Direct Patient Interface) devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.