DeVilbiss DV54D-HHRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885304001966), received between May 9, 2022 and May 9, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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

Recent adverse event reports

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

• MalfunctionMay 9, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  ON APRIL 13, 2022, DEVILBISS WAS NOTIFIED OF A COMPLAINT INVOLVING DEVILBISS DV54 INTELLIPAP AUTOADJUST¿ CPAP DEVICE BY A DISTRIBUTOR. THE DISTRIBUTOR WAS CONTACTED BY THE END USER, WHO REPORTED THAT ALL OF A SUDDEN, AFTER USING THE DEVICE OVERNIGHT, HE "WOKE UP WITH A NOSE FULL OF BLACK SNOW." THE DEVICE IS 13.5 YEARS OLD, AND THE END USER REPORTED THAT "DURING THE 13 YEARS HE HAS OWNED" THE DEVICE, "HE HAD NOT NOTICED ANYTHING ABNORMAL BEFORE THIS EVENT OCCURRED." THE END USER DID NOT REPORT ANY INJURY OR ILLNESS ASSOCIATED WITH THE EVENT. THE END USER REPORTED THAT HE "WENT TO THE DOCTOR, WHO REFERRED HIM TO A PULMONOLOGIST, WHO ADVISED HIM TO STOP USING THE MACHINE." THE DISTRIBUTOR REQUESTED THE END USER RETURN THE DEVICE FOR EVALUATION, WHICH THE PATIENT REFUSED TO DO, SO IT IS CURRENTLY UNCLEAR AS TO WHAT WOULD CAUSE ANYTHING THAT COULD BE DESCRIBED AS "BLACK SNOW" TO COME OUT OF THE DEVICE ALL OF A SUDDEN AFTER 13.5 YEARS OF NORMAL OPERATION. DEVILBISS IS ACTIVELY WORKING WITH THE DISTRIBUTOR TO SEEK PERMISSION TO CONTACT THE END USER DIRECTLY TO GATHER MORE INFORMATION AND RETRIEVE THE UNIT FOR A COMPREHENSIVE EVALUATION AND INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14335574 ↗