ELI 230 BUR230-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00812345023589), received between Mar 14, 2022 and Mar 14, 2022 — classified as 1 malfunction.

1 other recall cover devices cleared under the same FDA submission (K100127); they may or may not involve this specific model.

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.

• MalfunctionMar 14, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE CUSTOMER THAT AN ELI 230 WITH A DAMAGED POWER CABLE WOULD NOT CHARGE AND SHOCKED A USER. THE CUSTOMER HAS BEEN UNABLE TO IDENTIFY THE INDIVIDUAL WHO REPORTED THE EVENT. FOLLOW-UP ATTEMPTS WERE MADE WITH THE CUSTOMER; HOWEVER, THEY COULD NOT PROVIDE ANY FURTHER DETAILS OF LEVEL OF INJURY, MEDICAL INTERVENTION (IF ANY), AND OUTCOME. THE CUSTOMER CONFIRMED THERE HAS BEEN NO RECENT REPORT BY AN EMPLOYEE DUE TO A SHOCK RECEIVED AT THEIR FACILITY, THEREFORE, THEY BELIEVED THIS TO BE A MINOR SHOCK EVENT. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS C-(B)(4).

  Patient problems: Electric Shock

  MAUDE report 13757632 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K100127. One submission often covers many models, so check the product and lot details in each record.

• Z-1810-2020 · Mar 18, 2020 · Terminated
  Lead diagnostic electrocardiograph under the following device names: ELI 10, ELI 350, ELI 150c, ELI 250c, ELI 230, ELI 280, ELI 380, R-Scribe and Connex Cardio. Product Usage: A