Mobi 35001Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 09353645350018), received between Sep 14, 2020 and Sep 14, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Therapeutic or Diagnostic Output Failure” (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.

• MalfunctionSep 14, 2020Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO RESMED THAT A PATIENT USING A MOBI DEVICE FELT TIRED, LIGHTHEADED AND HAD AN OXYGEN DESATURATION DUE TO NO AIR PRESSURE COMING OUT OF THE DEVICE. PATIENT WAS PLACED ON AN ALTERNATE OXYGEN SOURCE AND O2 SATURATION INCREASED TO NORMAL LEVELS.

  Patient problems: Low Oxygen Saturation

  MAUDE report 10533020 ↗
• MalfunctionSep 14, 2020Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED TO RESMED THAT A PATIENT USING A MOBI DEVICE FELT TIRED, LIGHTHEADED AND HAD AN OXYGEN DESATURATION DUE TO NO AIR PRESSURE COMING OUT OF THE DEVICE. PATIENT WAS PLACED ON AN ALTERNATE OXYGEN SOURCE AND O2 SATURATION INCREASED TO NORMAL LEVELS.

  Patient problems: Low Oxygen Saturation

  MAUDE report 10532969 ↗