Freemie FG077Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00851690007455), received between Mar 2, 2019 and Mar 2, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Smoking” (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.

• MalfunctionMar 2, 2019Smoking; Smoking

  ON (B)(6) 2018 - CUSTOMER REPORTED THAT DEVICE WAS OVERHEATING. DEVICE WAS CLASSIFIED AS A "PUMP NOT WORKING" PER MDR ASSESSMENT THIS EVENT WAS NOT REPORTABLE. ON 12/03/2018 - DEVICE RECEIVED BY DAO HEALTH. ON 12/12/2018 - DEVICE WAS INVESTIGATED AND FOUND TO BE "LOW SUCTION MOTOR AND NOT GETTING POWER FROM THE BOARD (DID INITIALLY, THEN STOPPED). MOTOR RUNS ON THE POWER SUPPLY (BUT ONLY MAKES ABOUT 3 INHG). THE BOARD MAKES 6 VOLTS WHEN MEASURED AT THE PINS BUT DOES NOT RUN THE MOTOR." ON 02/04/2019 - DURING REVIEW OF THE ENGINEERING LOG, ENGINEERING DECIDED TO REVIEW THIS COMPLAINT AGAIN AND EXAMINED THE DEVICE. FURTHER INVESTIGATION DETERMINED THE "Q5 CHIP LOOKS LIKE IT MIGHT BE A LITTLE FRIED". FAILURE OF THE Q5 CHIP IS THE ROOT CAUSE FOR DAO HEALTH COMPLAINT CODE "SMOKING PUMP". ENGINEERING PROMPTLY NOTIFIED QUALITY SO THAT MDR COULD BE FILED. ON 02/04/2019 - BASED ON NEW INFORMATION, QUALITY BEGAN COLLECTION INFORMATION SO AN MDR COULD BE FILED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8384460 ↗