NA JB-102BRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04931921102879), received between Jun 26, 2017 and Jul 27, 2018 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Audible Prompt/Feedback Problem” (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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 27, 2018Audible Prompt/Feedback Problem; Audible Prompt/Feedback Problem

  THE EAR INSERTS THAT PROVIDE AEP (AUDITORY EVOKED POTENTIALS) STIMULATION DURING AN MEE-1000 PROCEDURE STIMULATED THE INCORRECT SIDES. THE MEE-1000 PC SYSTEM IS USED FOR EVOKED POTENTIALS, EEGS, AND EMGS. THESE EAR INSERTS HAD THESE ISSUES YEARS AGO AND THE MANUFACTURER OF THE EAR INSERTS HAS SINCE THEN CORRECTED THE ISSUE. THE CUSTOMER HAD THE OLD INSERTS THAT HAD THESE ISSUES, AND THEY WERE PROVIDED REPLACEMENT INSERTS THAT ARE FUNCTIONING CORRECTLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7728204 ↗
• MalfunctionJul 27, 2018Audible Prompt/Feedback Problem; Audible Prompt/Feedback Problem

  THE EAR INSERTS THAT PROVIDE AEP (AUDITORY EVOKED POTENTIALS) STIMULATION DURING AN MEE-1000 PROCEDURE STIMULATED THE INCORRECT SIDES. THE MEE-1000 PC SYSTEM IS USED FOR EVOKED POTENTIALS, EEGS, AND EMGS. THESE EAR INSERTS HAD THESE ISSUES YEARS AGO AND THE MANUFACTURER OF THE EAR INSERTS HAS SINCE THEN CORRECTED THE ISSUE. THE CUSTOMER HAD THE OLD INSERTS THAT HAD THESE ISSUES, AND THEY WERE PROVIDED REPLACEMENT INSERTS THAT ARE FUNCTIONING CORRECTLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7728199 ↗
• MalfunctionAug 24, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE CUSTOMER REPORTED THAT DURING AN OR PROCEDURE THAT THE MEE-1000 WAS NOT RECEIVING ANY STIMULUS OUTPUT. THE MEE-1000 SYSTEM IS USED FOR EVOKED POTENTIALS, EEGS, AND EMGS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6818812 ↗
• MalfunctionJun 26, 2017Device Operates Differently Than Expected; Computer Operating System Problem; Device Operates Differently Than Expected

  THE DC-110B MAIN UNIT WHICH HAS THE STIMMING CONTROLS, BECOMES DISCONNECTED FROM THE MEE-1000 PC SYSTEM WHICH IS USED FOR EVOKED POTENTIALS, EEGS, AND EMGS. THE MEE-1000A SOFTWARE NEEDS TO BE RESTARTED FOR THE DEVICE TO BE OPERABLE.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 6668623 ↗