EDGE SYSTEM 11996 (REF 11996-000093)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00883873784952), received between Feb 16, 2021 and Nov 8, 2024 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (8 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 8, 2024Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED ELECTRODES WERE IDENTIFIED WITH THE GEL PEELING FROM PADS. THESE WERE OPENED WHEN WELLINGTON HOSPITAL WAS CHECKING THE PADS ACROSS THE HOSPITAL WHEN THE ISSUE WAS FIRST IDENTIFIED. ALL THE PADS OPENED HAVE THE GEL ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20644401 ↗
• MalfunctionNov 8, 2024Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED THAT THE GEL IS PEELING FROM ELECTRODES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20643657 ↗
• MalfunctionOct 24, 2024Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED THAT THE GEL IS PEELING FROM ELECTRODES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20527285 ↗
• MalfunctionOct 23, 2024Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED ELECTRODES WERE IDENTIFIED WITH THE GEL PEELING FROM PADS. THESE WERE OPENED WHEN WELLINGTON HOSPITAL WAS CHECKING THE PADS ACROSS THE HOSPITAL WHEN THE ISSUE WAS FIRST IDENTIFIED. ALL THE PADS OPENED HAVE THE GEL ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20517308 ↗
• MalfunctionOct 16, 2024Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED THEY OPENED A SET OF RTS DEFIB ELECTRODES AND THE GEL WAS PEELING OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20461928 ↗
• MalfunctionOct 16, 2024Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED THEY OPENED A SET OF RTS DEFIB ELECTRODES AND THE GEL WAS PEELING OFF. PHARMACO WAREHOUSE CHECKED 4 ADDITIONAL UNITS IN THE WAREHOUSE AND 2 HAVE THE SAME ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20461764 ↗
• MalfunctionOct 16, 2024Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED THEY HAD A 22-MONTH INFANT IN ED YESTERDAY WITH SVT THAT REQUIRED CARDIOVERSION. THEY OPENED THE FIRST SET OF RTS DEFIB ELECTRODES AND THE GEL WAS PEELING OFF. THEY OPENED A SECOND SET AND SAME THING. THEY OPENED A THIRD SET AND THAT SET WAS FINE TO USE. ADDITIONAL INFORMATION RECEIVED ON 16OCT2024 STATED THAT THE THIRD SET OPENED WAS FINE TO USE, THE PATIENT DID NOT SUFFER ANY ADVERSE CONSEQUENCES AND RECOVERED FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20461549 ↗
• MalfunctionOct 16, 2024Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED THEY OPENED A SET OF RTS DEFIB ELECTRODES AND THE GEL WAS PEELING OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20461544 ↗
• MalfunctionFeb 16, 2021Connection Problem; Connection Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT PEDIATRIC DEFIBRILLATION ELECTRODES WOULD NOT STICK PROPERLY TO A 2 DAY OLD PATIENT. THE CUSTOMER ADVISED THAT THE PARAMEDICS WENT THROUGH 3 SETS OF ELECTRODES BEFORE BEING ABLE TO STICK CORRECTLY TO THE PATIENT. IN THIS STATE, DEFIBRILLATION THERAPY MAY BE DELAYED OR PREVENTED FROM BEING DELIVERED TO THE PATIENT IF NEEDED. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE EVENT REPORTED. THE CUSTOMER EMS ASSISTANT CHEIF MATT WALTRIP CONFIRMED THERE WAS NO SERIOUS INJURY OR DEATH RELATED TO THE USE OF THE DEVICE.

  Patient problems: Cardiac Arrest

  MAUDE report 11332633 ↗