Dome Electrodes 1Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI B618E0), received between Sep 19, 2023 and Sep 19, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Ambient Temperature Problem” (1 report).

1 other recall cover devices cleared under the same FDA submission (K190416); 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. 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.

• InjurySep 19, 2023Ambient Temperature Problem; Temperature Problem; Ambient Temperature Problem; Temperature Problem

  THE USER HAD HIS PROSTHESIS EXPOSED TO THE DIRECT SUNLIGHT IN 80+ DEGREE WEATHER FOR 12 HOURS. THIS CAUSED HIS DARK-COLORED PROSTHESIS TO HEAT UP. THIS HEAT WAS TRANSFERRED THRU THE PROSTHESIS SOCKET TO THE DOME ELECTRODES. BECAUSE THE DOME ELECTRODES ARE METAL THEY ARE GOOD AT CONDUCTING HEAT. THIS CAUSED THE HEAT TO BE TRANSFERRED FROM THE HOTTER PROSTHESIS SOCKET TO THE COOLER SKIN OF THE USER. THIS FACT WAS STRENGTHENED BECAUSE THE ELECTRODES CONCENTRATED THE HEAT AND THE AREAS OF THE BLISTERS WERE CLOSE TO THE DOME ELECTRODE PLACEMENT OF THE SOCKET. THEY WERE NOT EXACTLY LINED UP WITH THE DOME ELECTRODES, BUT VERY CLOSE. THIS IS ANOTHER REASON WE BELIEVE IT IS NOT AN ELECTRICAL BURN. IF IT WAS AN ELECTRICAL BURN, THE MARKS WOULD HAVE LINED UP EXACTLY WITH THE DOME ELECTRODES. THIS IS AN ISSUE THAT WE DID NOT SEE WITH THE GEN1 DEVICE. WE BELIEVE THIS TO BE THE RESULT OF A NUMBER OF COMPOUNDING FACTORS: 1) RECENT TRENDS IN PROSTHESES TO BE CONSTRUCTED OF ALL-BLACK SOCKET MATERIALS; 2) REDUCED POWER CONSUMPTION FROM THE GEN2 SYSTEM; AND 3) THE ENHANCED FUNCTIONAL PERFORMANCE OF THE GEN2 SYSTEM. WHEREAS SKIN-COLORED PROSTHESIS WERE POPULAR A FEW YEARS AGO, DARK COLORED SOCKETS, ES

  Patient problems: Skin Burning Sensation; Skin Discoloration; Skin Inflammation/ Irritation; Superficial (First Degree) Burn

  MAUDE report 17772545 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K190416. One submission often covers many models, so check the product and lot details in each record.

• Z-0203-2024 · Oct 2, 2023 · Open, Classified
  Coapt Dome Electrode, Gen2 system, cutaneous electrode