Skintact DF59NCRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 19005531506449), received between Apr 4, 2018 and Apr 6, 2022 — classified as 1 death, 3 malfunctions.

The most frequently reported specific device problem is “Defibrillation/Stimulation Problem” (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. 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.

• DeathApr 6, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  ON MARCH 22ND, 2022, WE HAVE BEEN INFORMED BY OUR DISTRIBUTOR (B)(4), ABOUT A MALFUNCTION WITH A DEFIBRILLATION ELECTRODE LOCATED IN (B)(6), FRANCE. THE INITIAL REPORT REPORTED: "ONE OF OUR CLIENT USING DF59NC ON (B)(6) 2022 ON A PATIENT WHO WAS IN CARDIO-RESPIRATORY ARREST, HAD A PROBLEM WITH THE DSA [DÉFIBRILLATEUR SEMI-AUTOMATIQUE] WHICH WAS SHOWING THE MESSAGE "POSITION ELECTRODE". THE EQUIPMENT HAD AT LEAST SWITCH OFF BY ITSELF. THE PATIENT DIED EVEN IF THE CLIENT HAD USED ANOTHER DSA (3 CHOCS) AND SMUR INTERVENTION USED ANOTHER DSA TOO (9 CHOCS)." ON (B)(6) 2022 WE HAVE RECEIVED A PARTIALLY FILLED IN QUESTIONNAIRE SPECIFYING THE DURATION OF THE PROCEDURE [TRANSLATED FROM (B)(6) TO ENGLISH LANGUAGE] AS "2H09 [2 HOURS AND 9 MINUTES] FROM THE ARRIVAL ON THE SCENE OF THE RESCUE TEAM (VSAV) UNTIL THE TRANSPORT OF THE VICTIM TO THE HOSPITAL." THE "NUMBER OF DEFIBRILLATION SHOCKS: 12 (3 + 9) WITH 2 OTHER DEVICES OF DIFFERENT MODELS." THE PATIENT WAS LYING DURING THE PROCEDURE ON HIS BACK. FURTHER ON WE HAVE BEEN INFORMED THAT HAIR WAS PRESENT UNDERNEATH THE APPLICATION SITE OF THE DEFIBRILLATION ELECTRODES. NO INFORMATION WAS PROVIDED IF ANY SKIN PREPARATION HAS BEEN DONE BEFORE APP

  Patient problems: Cardiac Arrest

  MAUDE report 14020822 ↗
• MalfunctionJan 13, 2022Melted; Melted

  ON (B)(6) 2021, WE HAVE BEEN INFORMED BY OUR DISTRIBUTOR (B)(6) ABOUT A MALFUNCTION WITH A DEFIBRILLATION ELECTRODE AT AN UNKOWN HEALTH CARE FACILITY. THE INITIAL REPORT SPECIFIED: "I HAVE RECEIVED A COMPLAINT FROM ONE OF OUR CLIENT REGARDING DF59NC LOT 210226-4019 WHICH SHOWS A PROBLEM ON THE CABLE." REQUESTING FURTHER INFORMATION ON THE MALFUNCTION WE HAD BEEN INFORMED THAT NO PATIENT WAS HARMED AND THAT THE CUSTOMER DETECTED TWO CONCERNED DEFIBNILLATION SETS. NO FURHER INFORMATION HAS BEEN MADE AVAILABLE ON THIS MALFUNCTION DESPITE REPEATED REQUESTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13249285 ↗
• MalfunctionJan 12, 2021Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  ON (B)(6) 2020 , WE HAVE BEEN INFORMED ABOUT A MALFUNCTION WITH A DEFIBRILLATION ELECTRODE SET AT SOUTH WESTERN AMBULANCE SERVICE NHS FOUNDATION TRUST IN UK. A DEFIBRILLATION ELECTRODE SET (MODEL SKINTACT DF59NC) WAS ABOUT TO BE CONNECTED TO A ZOLL AED PRO DEFIBRILLATOR. MRS. ALISON LOCKWOOD, WHO HAD FILED THE INITIAL COMPLAINT, STATED: "ATTENDED A WITNESSED CARDIAC ARREST WITH BYSTANDER CPR IN PROGRESS. RRV ARRIVED FIRST, CREW ATTACHED DEFIB PADDLES TO PATIENT. UNABLE TO OBTAIN READING FROM PADDLES- THINK DEFIB WAS REPEATING 'ATTACH PADS' DESPITE PADS ATTACHED TO PATIENT AND PLUGGED IN. RETAINED DCA CREW ARRIVED SHORTLY AFTERWARDS, ONE TRIED PUTTING DEFIB IN MANUAL MODE (THIS DID NOT HELP) WHILE OTHER WENT TO GET DCA DEFIB. PLUGGED PADS INTO DCA DEFIB AND STILL DID NOT READ. PADS REMOVED AND SECOND SET OF PADS APPLIED TO PATIENT, THESE WORKED IMMEDIATELY AND PEA RHYTHM IDENTIFIED. WHILE IT WAS UNLIKELY THAT THIS PATIENT WOULD 1) HAVE BEEN IN A SHOCKABLE RHYTHM AND 2) SURVIVED THE CARDIAC ARREST, HAD THIS BEEN A DIFFERENT PATIENT THIS COULD HAVE DELAYED AN EFFECTIVE SHOCK." ON JANUARY 04TH, 2021 WE HAVE RECEIVED A COMPLETED QUESTIONNAIRE SPECIFYING THE FOLLOWING INFORMATION: THE OB

  Patient problems: Cardiac Arrest

  MAUDE report 11153654 ↗
• MalfunctionApr 4, 2018Device Handling Problem; Device Handling Problem

  ON MARCH 08TH, 2018, WE HAVE BEEN INFORMED ABOUT A MALFUNCTION WITH A DEFIBRILLATION ELECTRODE SET AT (B)(6). A DEFIBRILLATION ELECTRODE SET (SKINTACT DF59NC) WAS CONNECTED TO A ZOLL AED PRO DEFIBRILLATOR. "DURING AN EMERGENCY SITUATION", SKINTACT DF59NC WERE USED. THE POUCH "WAS RIPPED OPEN ACROSS THE RIGHT SIDE OF THE PACKET AND PART WAY ACROSS THE TOP." "THE ELECTRODES WERE REMOVED FROM THE PACKET AND ATTACHED TO THE PATIENT. ONCE THE ELECTRODES WERE PLUGGED INTO THE EQUIPMENT, IT WAS NOTED THAT ONE OF THE WIRES WAS CUT. THE ELECTRODES WERE REMOVED AND A SECOND PACK USED." NO FURTHER INFORMATION ON THE PATIENT, THE PROCEDURE AND THE SKIN PREPARATION HAVE BEEN DISCLOSED SO FAR. THERE WAS NO REPORTED HARM TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7395178 ↗