Skintact DF28NRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 19005531501161), received between Jun 22, 2026 and Sep 28, 2026 — classified as 4 malfunctions.

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

• MalfunctionSep 28, 2026Electrical /Electronic Property Problem; Fitting Problem

  On August 25th, 2026, we have been informed about a malfunction with a defibrillation electrode set at (b)(6) HOSPITAL in the UK. Skintact defibrillation electrodes model DF28N and a Zoll defibrillator had been used. The initial MHRA report (MHRA Reference Number: (b)(4)) was stating that "We are regular users of the DF28N defibrillation pads, and over the past few weeks we have encountered a significant number of faulty items across multiple LOT numbers. The issue appears to be with the cable connection, which does not click into place securely. Defib pad connector cannot be pushed into the Zoll defib trunk cable. Loose electrical connection, at risk of disconnecting when in use. As a result, we are unable to use the affected pads, which is causing operational difficulties."On this form it was also stated that "All affected stock has been removed from the stockroom, discarded, and segregated from usable inventory. Using an alternative electrode from another supplier."No further details have been disclosed despite repeated requests.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50911351 ↗
• MalfunctionSep 15, 2026Electrical /Electronic Property Problem; Fitting Problem

  On August 20, 2026, we have been informed about a malfunction with a defibrillation electrodes at Worcestershire Acute Hospitals NHS Trust in the UK. Skintact defibrillation electrodes model DF28N and an Zoll defibrillator had been used. The initial report was stating that "Following the receipt of the above FSN's we have been using the Skintact Defib Electrodes, however, today we have identified that the pads aren't registering with the Zoll defibs we use." It was also specified that customer samples will be available for further investigation.No further details have been disclosed.We will provide a follow up report once any further information will become available.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50770682 ↗
• MalfunctionJul 7, 2026Fitting Problem; Connection Problem

  ON (B)(6) 2026, WE HAVE BEEN INFORMED ABOUT A MALFUNCTION WITH A DEFIBRILLATION ELECTRODE SET AT THE CUSTOMER ST. GEORGE'S HOSPITAL, CARDIAC CATHETER LABS. SKINTACT DEFIBRILLATION ELECTRODES OUR MODEL DF28N AND AN UNKNOWN ZOLL DEFIBRILLATOR HAD BEEN USED. THE INITIAL REPORT IS STATING THAT: " I AM WRITING FROM (B)(6) HOSPITAL, CARDIAC CATHETER LABS. WE ARE REGULAR USERS OF THE DF28N DEFIBRILLATION PADS, AND OVER THE PAST FEW WEEKS WE HAVE ENCOUNTERED A SIGNIFICANT NUMBER OF FAULTY ITEMS ACROSS MULTIPLE LOT NUMBERS. THE ISSUE APPEARS TO BE WITH THE CABLE CONNECTION, WHICH DOES NOT CLICK INTO PLACE SECURELY. AS A RESULT, WE ARE UNABLE TO USE THE AFFECTED PADS, WHICH IS CAUSING OPERATIONAL DIFFICULTIES." LATER ON, WE HAVE RECEIVED A COMPLAINT FORM. WITHIN THIS QUESTIONNAIRE IT WAS STATED THAT NO "MEDICAL/SURGICAL INTERVENTION REQUIRED" AND THAT "THE DEVICE (S) CHANGED OUT/REPLACED WITH NO FURTHER PROBLEMS ENCOUNTERED". IT WAS ALSO STATED THAT TWO LOT NUMBERS ARE CONCERNED: 260227-4044, 260319-5482. NO FURTHER DETAILS HAVE BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25729171 ↗
• MalfunctionJun 22, 2026Fitting Problem; Connection Problem

  ON (B)(6) 2026, WE HAVE BEEN INFORMED ABOUT A MALFUNCTION WITH A DEFIBRILLATION ELECTRODE SET AT THE CUSTOMER (B)(6). SKINTACT DEFIBRILLATION ELECTRODES OUR MODEL DF28N AND A ZOLL R SERIES DEFIBRILLATOR HAD BEEN USED. THE INITIAL REPORT IS STATING THAT "[TRANSLATED FROM GERMAN TO ENGLISH LANGUAGE]": "WITH ELECTRODES FROM THIS BATCH, THE CONNECTOR SOMETIMES FAILS TO ENGAGE PROPERLY. THE LOCKING MECHANISM DOESN'T ENGAGE BECAUSE THE CONNECTOR CANNOT SLIDE IN FAR ENOUGH OR IS TOO LONG. EXTREMELY DANGEROUS DURING RESUSCITATION - A SERIOUS DEFECT!" LATER ON, WE HAVE RECEIVED A PARTIALLY FILLED IN QUESTIONNAIRE. WITHIN THIS QUESTIONNAIRE IT WAS STATED THAT THE INCIDENT OCCURRED AT THE USER SITE (B)(6). NATURE OF THE PROCEDURE WAS A 5-10 MINUTE ELECTRICAL CARDIOVERSION AND A MONITORING LASTING FOR 4 HOURS. THE USAGE OF THE DEFIBRILLATOR WAS DESCRIBED AS BIPHASIC MODE MANUAL PROGRAM. IT WAS ALSO STATED THAT NO ADAPTER WAS USED. THE PATIENT WAS LYING ON THE HOSPITAL BED, SUPINE POSITION, UPPER BODY RAISED APPROXIMATELY 20° THROUGHOUT THE PROCEDURE. THE USER CONNECTED THE ELECTRODES TO THE PATIENT. WHEN THEY PLUGGED IN THE CONNECTOR, THE LOCKING MECHANISM DID NOT ENGAGE. THEY REMOVED THE ELEC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25576473 ↗