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DeVilbiss DV54DRecalls & reported problems

Devilbiss Healthcare LLC · IntelliPAP Auto Adjust · Class 2

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885304001881), received between Jul 19, 2023 and Jul 19, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Degraded” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Degraded1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionJul 19, 2023Degraded; Degraded

    ON JUNE 21, 2023 DEVILBISS RECEIVED A COMPLAINT FROM AN END-USER REGARDING A DEVILBISS DV54 SERIES CPAP DEVICE, PURCHASED IN 2013 (5 YEARS BEYOND THE EXPECTED SERVICE LIFE AT THE TIME OF THE REPORT). THE END-USER STATED THE UNIT WAS OPERATING AS INTENDED, AND HE HAD NO COMPLAINTS OF ILLNESS OR INJURY, NOR DID HE SEEK MEDICAL ATTENTION ASSOCIATED WITH HIS USE OF THE DEVICE. DESPITE NO COMPLAINTS OF ILLNESS OR INJURY, OR ANY EVIDENCE OF PERFORMANCE ISSUES OR A DEVICE MALFUNCTION, THE END-USER STATED THAT BASED ON THE NEWS REGARDING THE PHILIPS CPAP PE-PUR FOAM ISSUES, HE DISASSEMBLED THE DEVICE TO EXAMINE THE FOAM AND OBSERVED SOME DEGRADATION OF THE FOAM. ON JUNE 27, 2023 DEVILBISS IDENTIFIED A RELATED MAUDE FILING (MW 5118808) FROM THE SAME END-USER REGARDING A DV5 CPAP DEVICE. THE COMPLAINT IN THE MAUDE STATES, "I AM A CPAP USER. I HAVE BOUGHT A DEVILBISS DV54D ONLINE FROM THE US. I AM A MALAYSIAN RESIDENT. DUE TO THE PHILIPS RECALL ON THE FOAM ISSUES, I HAVE OPENED MY CPAP MACHINE UP AND TO MY HORROR, THE FOAM FOR THE DEVILBISS HAVE DEGRADED AND THE FOAM PARTICLES AND SHEDDING IS ALL OVER THE FAN MOTOR AND THE CHAMBER. I HAVE NO RELATED SYMPTOMS BUT WORRY OF THE LONG TERMS RISK F

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17351702 ↗

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