SimplyGo Mini SimplyGo Mini with Extended Battery, ITRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00606959048843), received between Jan 22, 2024 and Jan 22, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Contamination” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• MalfunctionJan 22, 2024Contamination; Gas Output Problem; Overheating of Device; Noise, Audible; Contamination; Gas Output Problem; Overheating of Device; Noise, Audible

  A SIMPLYGO MINI DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THERE WAS NO REPORT OF MEDICAL INTERVENTION. DURING THE DEVICE EVALUATION, THE THIRD-PARTY SERVICE CENTER VISUALLY INSPECTED THE DEVICE AND FOUND THE UNIT NOISY, LOW O2, IRREGULAR GRAPH COMPRESSOR CONTAMINATED AND OVERHEATING, SIEVES RECIPES CLOGGED, O2 SIDE, AIRSIDE DEFECTIVE. THE DEVICE HAS BEEN SERVICED, INSPECTED, TESTED, AND MET ALL ACCEPTANCE CRITERIA. ALL TEST RESULTS HAVE PASSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18554772 ↗