SkintactRecalls & reported problems across all models
Leonhard Lang GmbH · 14 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 26
- Deaths reported
- 1
- Injuries reported
- 7
- Recalls
- 0
We found 14 models of Skintact by Leonhard Lang GmbH in the FDA's device registry (GUDID). Together they are named in 26 adverse event reports in the FDA's MAUDE database, received between Jan 26, 2016 and Sep 28, 2026 — classified as 1 death, 7 injuries, 18 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (9 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Skintact problems
Device problems
- Insufficient Device Problem Information9
- Fitting Problem8
- Electrical /Electronic Property Problem3
- Connection Problem2
- Mechanical Problem2
- No Apparent Adverse Event2
- Defective Component1
- Defective Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions9
- Skin Inflammation/ Irritation3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Burn(s)2
- Cardiac Arrest2
- No Consequences Or Impact To Patient2
- No Known Impact Or Consequence To Patient2
- Skin Irritation2
Skintact models
14 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Skintact DF28NAutomated External Defibrillators (Non-Wearable)4 reports
- Skintact DF59NCAutomated External Defibrillators (Non-Wearable)1 death4 reports
- Skintact T-VO01Electrode, Electrocardiograph3 reports
- Skintact DF27NAutomated External Defibrillators (Non-Wearable)3 reports
- Skintact DF29NAutomated External Defibrillators (Non-Wearable)2 reports
- Skintact DF20NAutomated External Defibrillators (Non-Wearable)2 reports
- Skintact DF28NCAutomated External Defibrillators (Non-Wearable)1 report
- Skintact DF20NCAutomated External Defibrillators (Non-Wearable)1 report
- Skintact FS-RG1 /10Electrode, Electrocardiograph1 report
- Skintact DF27NCAutomated External Defibrillators (Non-Wearable)1 report
- Skintact DF59NAutomated External Defibrillators (Non-Wearable)1 report
- Skintact T-60Electrode, Electrocardiograph1 report
- Skintact RO21 /5Electrosurgical, Cutting & Coagulation & Accessories1 report
- Skintact RS25A30Electrosurgical, Cutting & Coagulation & Accessories1 report
Recent Skintact adverse event reports
The 15 most recent reports across all models, 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 ↗InjuryJul 16, 2026Insufficient Device Problem Information
ON (B)(6) 2026, WE HAVE BEEN INFORMED ABOUT AN INCIDENT WITH ECG ELECTRODES. MONITORING ECG ELECTRODES (MODEL TVO01) HAD BEEN USED AT HERZPRAXIS (B)(6). THE INITIAL REPORTER INFORMED LEONHARD LANG ABOUT A PATIENT INCIDENT. IT WAS STATED: "A CARDIOLOGY PRACTICE HAS COMPLAINED THAT PATIENTS FREQUENTLY REPORT ITCHING AND REDNESS FROM THE ELECTRODES, WHICH CAN REMAIN VISIBLE FOR DAYS. TWO PATIENTS EVEN DEVELOPED BLISTERS ON THEIR SKIN." ON (B)(6) 2026 WE HAVE RECEIVED A FILLED IN QUESTIONAIRE. A 48-HOUR ECG MONITORING WAS PERFORMED. THE PATIENT WAS DESCRIBED AS SLIM AND THE PATIENT SKIN WAS DESCRIBED AS NORMAL, "RATHER DRY, BODY HAIR? NO TATTOOS". A MORTARA H12+ ECG DEVICE AND MEDILAN CABLES HAVE BEEN USED. 7 ECG ELECTRODE HAVE BEEN APPLIED ON THE PATIENT'S CHEST. THE SKIN PREPARATION WAS DESCRIBED AS CLEANED WITH "ALCOHOL ISOPROPYLICUS PROPAN-2-OL", SHAVEN? DISINFECTED WITH "ALCOHOL ISOPROPYLICUS PROPAN-2-OL", NO OINTMENT HAS BEEN USED BUT THE SKIN WAS DRIED. IT WAS ALSO REPORTED THAT " THE ADHESIVE STRENGTH IS GOOD, BUT SKIN REACTION IS A PROBLEM." THE ELECTRODES ADHERED WELL AND WERE NOT REPOSITIONED. ON (B)(6) 2026 WE HAVE RECEIVED FURTHER INFORMATION AND TWO PICTURES SHOWING THE P
Patient problems: Localized Skin Lesion; Skin Inflammation/ Irritation
MAUDE report 25835655 ↗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 ↗MalfunctionMar 30, 2026Mechanical Problem
ON (B)(6) 2026, WE HAVE BEEN INFORMED BY A CUSTOMER ABOUT A FAILURE WITH A DEFIBRILLATION ELECTRODE SET. SKINTACT DEFIBRILLATION ELECTRODES OUR MODEL DF20N HAD BEEN DETECTED AS DEFECTIVE. THE INITIAL REPORT IS STATING THAT: "THE PACKAGING BAG IS NOT SEALED." WE ALSO RECEIVED ONE PICTURE SHOWING THE CLAIMED DEFECT. REVIEWING THE CUSTOMER PICTURE IT IS VISIBLE AN UNSEALED POUCH SEALING AT THE TOP OF THE POUCH. FOR A FURTHER ROOT CAUSE ANALYSES, WE HAVE REQUESTED THE CONCERNED CUSTOMER POUCH. NO FURTHER DETAILS HAVE BEEN DISCLOSED SO FAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24725945 ↗MalfunctionFeb 4, 2026Mechanical Problem
ON JANUARY 12, 2026, WE HAVE BEEN INFORMED ABOUT A MALFUNCTION WITH A DEFIBRILLATION ELECTRODE SET AT (B)(6) HOSPITAL IN THE UK. SKINTACT DEFIBRILLATION ELECTRODES MODEL DF27N AND AN UNKNOWN DEFIBRILLATOR HAD BEEN USED. THE INITIAL REPORT WAS STATING THAT "THE MAGNET ON THE CONNECTOR RAISED SO WOULD NOT SLIP IN TO DEFIB". ADDITIONALLY, WE HAVE RECEIVED TWO PICTURES SHOWING THE CLAIMED FAILURE. ON ONE OF THE TWO PICTURES, IT IS CLEARLY VISIBLE THAT THE MAGNETIC INSERT OF THE PLUG IS PROTRUDING OUT OF ITS SOCKET. ON THE OTHER PICTURE, THE PLUG IS ONLY SEEN IN THE TOP SIGHT. NO VISUAL DAMAGES OR OTHER DEVIATIONS OF THE PLUG CAN BE SEEN ON THE CUSTOMER PICTURES. IT WAS ALSO SPECIFIED THAT THE CONCERNED SAMPLE WILL BE AVAILABLE FOR FURTHER INVESTIGATION. WE ARE THEREFORE AWAITING THE CONCERNED SAMPLE. WE WILL PROVIDE A FOLLOW UP REPORT ONCE ANY FURTHER INFORMATION WILL BECOME AVAILABLE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24256049 ↗InjuryDec 9, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
ON (B)(6) 2025, WE HAVE BEEN INFORMED ABOUT AN INCIDENT WITH ECG ELECTRODES AT (B)(6) HOSPITAL, (B)(6). SKINTACT ELECTRODES MODEL TVO01 WERE USED. THE INITIAL REPORTER STATED THAT "WE USE YOUR SKINTACT T-VO01 ELECTRODES FOR EVENT MONITORING AND HAVE AROUND 7 PATIENTS PER WEEK. IN THE LATEST MONTHS WE HAVE SEEN AN INCREASE IN PATIENTS WHO DEVELOP SKIN RASHES AND CAN'T CONTINUE USING THE ECG-DEVICE BECAUSE OF IT. THESE ARE PATIENTS WITH NO PREVIOUSLY KNOWN SKIN CONDITIONS. I'M WONDERING IF THERE MAY HAVE BEEN A CHANGE IN MANUFACTURING THE SKINTACT ELECTRODES THAT MAY GIVE THESE RESULTS? (ONE OF OUR CURRENT LOT NUMBERS ARE 250313-0245 WITH GTIN 19005531505480). SINCE WE HAVE A PROCUREMENT DEPARTMENT AT THE HOSPITAL, WE'RE SOMEWHAT LIMITED IN REGARD TO CHOOSING WHICH MATERIALS TO USE, BUT I WONDERING IF PERHAPS THE T-VO02 MAY BE MORE SUITABLE FOR SENSITIVE SKIN? I CAN'T SEE MUCH DIFFERENCE IN THE TYPES OF MATERIAL USED THOUGH" WE HAVE REQUESTED FURTHER INFORMATION AND RECEIVED ON (B)(6) 2025 A FILLED IN QUESTIONNAIRE. WITHIN THE QUESTIONNAIRE IT WAS STATED THAT THE INCIDENTS OCCURRED FROM "SPRING TO WINTER OF 2025" AND THAT "THIS CONCERNS >10 PATIENTS, ANSWERS BELOW ARE ON GROUP LEVEL"
Patient problems: Blister; Itching Sensation; Skin Inflammation/ Irritation
MAUDE report 23754998 ↗MalfunctionOct 23, 2025No Apparent Adverse Event; No Apparent Adverse Event
ON (B)(6) 2025, WE HAVE BEEN INFORMED ABOUT A MALFUNCTION WITH A DEFIBRILLATION ELECTRODE SET AT AN UNKNOWN USER SITE IN THE UK. SKINTACT DEFIBRILLATION ELECTRODES MODEL DF27NC AND A PHILIPS FR2+ DEFIBRILLATOR HAD BEEN USED. THE INITIAL WAS STATING THAT "I AM ENCOUNTERING SOME ISSUES WITH THE DEFIBRILATOR PADS FOR PHILIPS FR. THE DEFIBRILLATOR DOES NOT RECOGNISE THEM (THE PADS) WHEN PLUGGED IN." WE HAVE REQUESTED FURTHER INFORMATION AND HAVE RECEIVED LATER ON PICTURES AND A VIDEO SHOWING THE CLAIMED FAILURE. NO FURTHER DETAILS HAVE BEEN DISCLOSED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions
MAUDE report 23364577 ↗MalfunctionOct 15, 2025No Apparent Adverse Event; No Apparent Adverse Event
ON SEPTEMBER 24TH, 2025, WE HAVE BEEN INFORMED ABOUT A MALFUNCTION WITH A DEFIBRILLATION ELECTRODE SET AT (B)(6) HOSPITAL IN (B)(6). SKINTACT DEFIBRILLATION ELECTRODES MODEL: DF20N AND AN UNKNOWN DEFIBRILLATOR HAD BEEN USED. THE INITIAL REPORT STATED THAT "-ELECTRODE REPEATEDLY FAILED TO SHOCK PATIENT. PATIENT IS OF STOCKY BODY, DEFIBRILLATOR SETTING WAS MANUAL. PATIENT WAS NOT HARMED." WE HAVE REQUESTED FURTHER INFORMATION, A FILLED IN QUESTIONNAIRE BUT NONE HAVE BEEN RECEIVED SO FAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23297909 ↗MalfunctionMay 27, 2025Defective Component; Defective Device; Patient Device Interaction Problem; Defective Component; Defective Device; Patient Device Interaction Problem
ON MAY 2ND, 2025, WE HAVE BEEN INFORMED ABOUT A MALFUNCTION WITH A DEFIBRILLATION ELECTRODE SET AT (B)(6) IN THE UK. SKINTACT DEFIBRILLATION ELECTRODES MODEL DF28NC AND A ZOLL R SERIES PLUS DEFIBRILLATOR HAD BEEN USED. THE INITIAL MHRA REPORT (MHRA REFERENCE NUMBER: (B)(4)) WAS STATING THAT "SUSPECT SKINTACT DEFIB PADS THAT FAILED TO RECORD ECG ON THE DEFIBRILLATOR, POST SHOCK. DEVICE BEING USED WAS A ZOLL R SERIES PLUS. (COMPATIBLE CONSUMABLE)" WE HAVE REQUESTED FURTHER INFORMATION AND HAVE RECEIVED A FILLED IN CUSTOMER FORM SPECIFYING THAT IT WAS "UNABLE TO PICK UP TRACE/ECG FROM PADS". FURTHER ON IT WAS STATED ON THE FORM "QUARANTINED DEFIB & PADS. CONDUCTED A FULL ASSESSMENT AND TEST OF DEFIB (NO FAULTS FOUND)". ON THIS FORM IT WAS ALSO STATED THAT THE DEFIBRILLATION PROCEDURE LASTED FOR ABOUT 10 - 15 MINUTES. IF A SERIOUS INJURY AND MEDICAL /SURGICAL INTERVENTION WAS REQUIRED IT WAS SPECIFIED TO BE "UNKNOWN". FURTHER ON IT WAS STATED THAT THE INVOLVED DEVICE IS AVAILABLE FOR TESTING. NO FURTHER DETAILS HAVE BEEN DISCLOSED DESPITE REPEATED REQUESTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22086195 ↗InjuryDec 17, 2024Use of Device Problem; Use of Device Problem
ON (B)(6) 2024, WE HAVE BEEN INFORMED ABOUT AN INCIDENT INVOLVING A DISPERSIVE ELECTRODE AT (B)(6) UK. A MONITORING DISPERSIVE ELECTRODE [SPLIT ELECTROSURGICAL NEUTRAL ELECTRODE] SKINTACT MODEL RO21/5 AND AN UNKNOWN GENERATOR HAVE BEEN USED. THE DISPERSIVE ELECTRODE WAS PLACED ON THE PATIENT'S ABDOMEN AND AN EYE SURGERY WAS PERFORMED. THE INITIAL REPORT STATES "I WOULD LIKE TO RAISE MY CONCERN OVER THE NEUTRAL ELECTRODE PADS WHICH WE USE DURING THE MINOR LIST PROCEDURES WHEN WE USE SAFE AIR. ONE OF OUR PATIENTS HAS DEVELOPED SOME BLISTERS DUE TO THE NEURAL ELECTRODE PAD WHICH WE HAVE USED IN THE SURGERY." ADDITIONALY TO THE INITIAL COMPLAINT WE RECEIVED A PICTURE NOT SUITABLE TO SPECIFY THE LOCATION ON THE PATIENT BODY. HOWEVER TWO SMALL BLISTERS CAN BE SEEN. A SECOND PICTURE IS SHOWING A 2 PENCE COIN AND A PIECE OF PLASTIC WHICH IS A RESIDUE FROM THE LIFTING AID. THE TWO PICTURES HAVE BEEN COMMENTED BY THE INITIAL REPORTER "PHOTOS OF BLISTERS AND PLASTIC DRESSING WHICH WAS STUCK OVER THE LEFT HAND BLISTER (WHICH IS ON THE RIGHT AS YOU SEE THE PICTURE ). THE BIGGER BLISTER ( ON THE LEFT AS YOU SEE IT) LOOKS THE WORST. I HAVE PUT A TWO PENCE PIECE NEXT TO THE PIECE OF PLASTIC TO SHO
Patient problems: Burn(s); Skin Inflammation/ Irritation
MAUDE report 20949397 ↗InjuryMay 16, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
ON APRIL 26TH, 2024, WE HAVE BEEN INFORMED ABOUT AN INCIDENT WITH ECG ELECTRODES. MONITORING ECG ELECTRODES (MODEL TVO01) HAD BEEN USED AT MID YORKSHIRE NHS TEACHING TRUST. THE INITIAL REPORTER INFORMED LEONHARD LANG ABOUT A PATIENT INCIDENT. IT WAS STATED: "I HAVE A PATIENT INCIDENT WHERE THE ELECTRODES HAVE ACTUALLY BURNT THE PATIENTS SKIN I DO HAVE PHOTOGRAPHS." ON MAY 08TH, 2024 WE HAVE RECEIVED A PICTURE SHOWING THE SKIN INJURY AND A PARTIALLY FILLED IN QUESTIONAIRE. A "24 HOUR AMBULATORY ECG" MONITORING WAS PERFORMED. THE PATIENT SKIN WAS DESCRIBED AS NORMAL. THE MEDICAL HISTORY WAS DESCRIBED AS "NO KNOWN ALLERGIES - PATIENT WAS ASKED AT THE TIME OF FITTING ". 3 ECG ELECTRODE HAVE BEEN APPLIED ON THE PATIENTS CHEST. THE SKIN PREPARATION WAS DESCRIBED AS CLEANED WITH "AMBU SKIN PREP PAD", NOT SHAVEN, DISINFECTED WITH "CLINELL 2% CHLORHEXIDINE IN 70% ALCOHOL SKIN WIPE", NO OINTMENT HAS BEEN USED AND DRIED WITH PAPER TOWEL. HOURS AFTER THE TREATMENT THE PATIENT NOTICED AT HOME IN THE "RIGHT UPPER CHEST AREA BURNING AND SORE, BLISTERS APPEARED". IT WAS DESCRIBED "PATIENT WAS SLEEPING - WOKE UP WITH A BURNING SENSATION AROUND 3 AM WHERE THE UPPER STICKER WAS PLACED". NO INFORMATIO
Patient problems: Burn(s)
MAUDE report 19329446 ↗InjuryFeb 28, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
ON JANUARY 31ST, 2023, WE HAVE BEEN INFORMED ABOUT AN INCIDENT WITH ECG ELECTRODES IN ALLERGOLOGY IN A PUBLIC HOSPITAL OSPEDALE SAN GIOVANNI DI DIO, IN FLORENCE, ITALY. SKINTACT ELECTRODES MODEL FS-RG1/10 WERE USED. THE INITIAL REPORTER WAS REQUIRING "ONE PATIENT SHOWED SUSPICIOUS ALLERGIC DERMATITIS AFTER USING YOUR ELECTROCARDIOGRAM ELECTRODES FS-RG1/10. THEREFORE I ASK YOU ABOUT THE CHEMICALS THAT CONSTITUTE EACH PART OF THE ELECTRODES (E.G. THE FOAM, THE GLUE...)." NO FURTHER DETAILS HAVE BEEN DISCLOSED DESPITE REPEATED REQUESTS.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 16451138 ↗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 ↗
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page