DeVilbiss DV51DRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885304001843), received between Jul 19, 2022 and Dec 22, 2022 — classified as 1 death, 1 malfunction.

The most frequently reported specific device problem is “Fire” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 22, 2022Material Discolored; Material Puncture/Hole; Material Discolored; Material Puncture/Hole

  DEVILBISS HEALTHCARE WAS NOTIFIED VIA A MEDWATCH REPORT #MW5113485 OF A COMPLAINT INVOLVING A DEVILBISS CPAP MACHINE. THE MEDWATCH REPORT WAS FILED BY THE END-USER, WHO STATED "I NOTED BLACK DEBRIS IN MY CPAP HOSE. I TOOK THE MACHINE APART AND FOUND A HOLE WAS TORN [IN THE FOAM] NEAR THE CIRCULATION PUMP [FLOW GENERATOR]." HE ALSO STATE "THE FOAM INSULATION TURNED INTO A BLACK STICKY TAR LIKE SUBSTANCE." DEVILBISS INITIATED AN INVESTIGATION, INCLUDING A DISCUSSION WITH THE END-USER, WHO CLAIMS TO HAVE BEEN USING THE DEVILBISS CPAP FOR MORE THAN 5 YEARS. THE SERIAL NUMBER OF THE UNIT CONFIRMS THE DEVICE WAS SOLD 9.5 YEARS AGO, WHICH AT THE TIME OF THE INCIDENT WAS NEARLY TWICE THE 5-YEAR EXPECTED SERVICE LIFE OF THE UNIT. THE END-USER STATED HE USED THE CPAP DEVICE NIGHTLY FOR APPROXIMATELY 8 HOURS, AND HAS NOT EXPERIENCED ANY ILLNESS OR INJURY RELATING TO THIS COMPLAINT. HE ALSO CONFIRMED HE STOPPED USING THE DEVICE SINCE OBSERVING THE DEBRIS IN THE TUBING (HE HAS ANOTHER DEVICE). HE NOTED THAT APPROXIMATELY THREE YEARS AGO HE BEGAN CLEANING THE CPAP UNIT DAILY WITH AN OZONE CLEANING DEVICE (SOCLEAN®) FOR 12 MINUTES, AND EXPRESSED CONCERN THE USE OF THE OZONE CLEANER "MAY HAVE CAUS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16039494 ↗
• DeathJul 19, 2022Fire; Fire

  DEVILBISS HEALTHCARE WAS NOTIFIED OF A FIRE THAT OCCURRED IN A HOUSE WHERE A PATIENT WAS USING A DEVILBISS CPAP MACHINE, ALONG WITH SEVERAL OTHER ELECTRICAL APPLIANCES. THE INSURER FOR THE HOUSE REPORTED THAT "PRELIMINARY INVESTIGATION DETERMINED THE FIRE WAS CAUSED BY A CPAP SYSTEM LEADING TO PROPERTY DAMAGE AND LOSS OF LIFE." DEVILBISS HAS PARTICIPATED IN THE INSPECTION OF THE FIRE SCENE WITH SEVERAL PARTIES AND WILL CONTINUE TO PARTICIPATE IN THE INVESTIGATION OF THE CAUSE AND ORIGIN OF THE FIRE, AND WILL PROVIDE AN UPDATE WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15052841 ↗