SimplyGo Mini SimplyGo Mini, JPRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00606959047433), received between Dec 15, 2023 and Dec 15, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Gas/Air Leak” (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 16, 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.

• MalfunctionDec 15, 2023Gas/Air Leak; Noise, Audible; Gas/Air Leak; Noise, Audible

  THE MANUFACTURER RECEIVED INFORMATION REGARDING A SIMPLYGO MINI. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S SERVICE CENTER. DURING THE DEVICE INVESTIGATION, A SIEVE ALARM DISPLAYED A MESSAGE STATING, "SIEVE CANISTER NEEDS CHECKED". THE CANISTER ASSEMBLY WAS REPLACED. THE SILICONE TUBE WAS FOUND TO HAVE BEEN WORN AWAY BY CONTACTING THE REAR CASE. THE SILICONE TUBE WAS REPLACED. DURING FURTHER INVESTIGATION OF THE DEVICE, A LEAK WAS FOUND WITHIN THE DEVICE. THE SIEVE O2 SIDE ASSEMBLY WAS REPLACED AS A RESULT. DURING OPERATION OF THE DEVICE, A NOISE WAS DETECTED. THE AIRSIDE MANIFOLD WAS REPLACED AS A RESULT. DAMAGE TO THE APPEARANCE OF THE AC POWER ADAPTER WAS OBSERVED. THE AC POWER ADAPTER WAS SUBSEQUENTLY REPLACED. NO THERMAL DAMAGE NOR ANY EXPOSED WIRES WERE PRESENT. THERE WAS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18341290 ↗