CHATTANOOGA 2786Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888912294140), received between Dec 26, 2019 and Jun 27, 2022 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Intermittent Energy Output” (2 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 27, 2022Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE THE UNIT ALLEGEDLY CAUSED A BURN TO PATIENT DURING STIM TREATMENT.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 14837167 ↗
• InjuryJan 7, 2022Device Displays Incorrect Message

  IT WAS REPORTED THAT THE DEVICE ALLEGEDLY EXPERIENCED AN ERROR CODE, BURNED A PATIENT AND THE UNIT SHUTS OFF DURING TREATMENT.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 13198893 ↗
• MalfunctionSep 23, 2020No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT "THE UNIT WAS SHOCKING PATIENTS." DEVICE NOT RECEIVED MANUFACTURER AT THIS TIME. MANUFACTURER IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 10575069 ↗
• MalfunctionJun 4, 2020Unintended Electrical Shock; Unintended Electrical Shock

  IT WAS REPORTED THAT THE UNIT WAS "SHOCKING PATIENTS DURING TREATMENT." THERE HAS BEEN NO REPORTED PATIENT INJURY OR HARM AT THIS TIME. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. IF THE DEVICE IS RETURNED, A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF DEVICE EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10118258 ↗
• MalfunctionFeb 3, 2020Intermittent Energy Output; Intermittent Energy Output

  IT WAS REPORTED THAT "WHEN INCREASING OR DECREASING INTENSITY KNOB, THE INTENSITY WILL FLUCTUATE INCREASING AND DECREASING THE INTENSITY. INTENSITY IS NOT STABLE WHEN NOT MOVING THE KNOB." THIS REPORTEDLY OCCURRED DURING TREATMENT, BUT NO PATIENT HARM WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9659576 ↗
• MalfunctionDec 26, 2019Intermittent Energy Output; Intermittent Energy Output

  IT WAS REPORTED THAT DURING A TREATMENT, THE INTENSITY ROSE UP TO 30MA AND THEN IMMEDIATELY SHUT OFF". THERE WAS NO REPORTED PATIENT HARM. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9519379 ↗