Neuropack S1 DC-940BARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04931921102183), received between May 25, 2018 and Oct 14, 2019 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 14, 2019Energy Output Problem; Energy Output Problem

  THE EEG TECH REPORTED THAT THE STIMULATOR CONNECTED TO THE MEB-9400A SYSTEM WOULD NO LONGER DELIVER STIMULATION, AND THAT THE STIMULATION INTENSITY WAS CHANGING ON ITS OWN. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 9189063 ↗
• MalfunctionJan 4, 2019Temperature Problem; Appropriate Device Problem Term/Code Not Available; Temperature Problem; Appropriate Device Problem Term/Code Not Available

  THE CUSTOMER REPORTED THAT THERE WAS A BURNING SMELL FROM THE POWER SUPPLY FROM THEIR MEB-9400A SYSTEM AFTER IT HAD SHUTDOWN. THEY GOT IT RUNNING FOR A LITTLE WHILE IN SAFE MODE AND WOULD LIKE THE SYSTEM EVALUATED. HOWEVER, THEY HAVE ORDERED A REPLACEMENT AND ARE AWAITING ITS ARRIVAL BEFORE TAKING THIS UNIT OFFLINE. THE CALLER AND THEIR IT PERSON EXPRESSED THEY WANTED TO KEEP THE SYSTEM IN USE AFTER I EXPLAINED THE SYSTEM MAY BE A HAZARD TO THE PATIENTS. NO PATIENT HARM OR INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8220327 ↗
• MalfunctionDec 7, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE CUSTOMER REPORTED THAT THE EMG (ELECTROMYOGRAPHY) DATA RECORDED UNDER ANOTHER PATIENT'S NODE. WE CONTACTED TO THE CUSTOMER TO VERIFY IF THIS WAS DONE IN USER ERROR WHERE AN INCORRECT PATIENT NAME WAS CHOSEN WHEN THE STUDY WAS STARTED. HOWEVER, THE CUSTOMER WAS NOT SURE HOW IT HAPPENED AND STATED THAT THIS WAS A SINGLE-TIME OCCURRENCE. WE DID ASK TO LOOK INTO THEIR DEVICE REMOTELY TO COLLECT INFORMATION BUT THEY REFUSED TO DO THAT. NO PATIENT HARM OR INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8144261 ↗
• MalfunctionMay 25, 2018Use of Device Problem; Device Operates Differently Than Expected; Use of Device Problem; Device Operates Differently Than Expected

  THE DOCTOR REPORTED THAT THERE IS INACCURATE MARKING OF ONSET LATENCY WHEN TESTED ON SENSORY NERVES AND WHEN TESTED ON ALL MOTOR NERVES. THEY STATED THAT THIS HAS RESULTED IN AN INACCURATE DIAGNOSIS TO A PATIENT. WE HAVE ATTEMPTED TO CONTACT THE CUSTOMER TO INQUIRE ABOUT THE STATUS OF THE PATIENT TO FURTHER TROUBLESHOOT, AND TO PROVIDE ADDITIONAL TRAINING ON THE USAGE OF THE DEVICE. THE CUSTOMER WAS INSTRUCTED TO CONTACT NKA, BUT THEY HAVE NOT RESPONDED BACK TO US.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7546759 ↗