Skintact DF29NRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 19005531500287), received between Aug 25, 2016 and Aug 25, 2016 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fitting Problem” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2016Fitting Problem; Fitting Problem

  ON (B)(6), WE HAVE BEEN INFORMED ABOUT A MALFUNCTION WITH A DEFIBRILLATION ELECTRODE AT AN UNKNOWN LOCATION IN THE (B)(6). A WELCH ALLYN AED10 DEFIBRILLATOR AND A SKINTACT DEFIBRILLATION ELECTRODE SET (DF29N) WERE USED. THE ELECTRODES WERE APPLIED IN A ROUTINE COURSE OF A SURGICAL PROCEDURE ON THE PATIENT AS A PRECAUTION. WHEN THE OPERATOR APPLIED THE ELECTRODES ON THE PATIENT AND TRIED TO PLUG THE CONNECTOR INTO THE DEFIBRILLATOR, HE HAD DIFFICULTIES TO FULLY INSERT IT INTO THE MACHINE. THE INITIAL REPORT DISCLOSED: "IT APPEARS THAT YOUR PRODUCT, CODE: DF29N DOES NOT FIT THE MACHINE (...). UNABLE TO PUSH THE CONNECTOR FAR ENOUGH TO CONNECT." THE OPERATOR TRIED OTHER ELECTRODES FROM THE SAME BATCH BUT ENCOUNTERED THE SAME ISSUE. NO PATIENT WAS HARMED OR PUT AT AN EXTRA RISK BY THIS INCIDENT.

  Patient problems: No Information

  MAUDE report 5902788 ↗
• MalfunctionAug 25, 2016Fitting Problem; Fitting Problem

  ON AUGUST 1ST, WE HAVE BEEN INFORMED ABOUT AN ADVERSE EVENT WITH A DEFIBRILLATION ELECTRODE SET, MODEL DF29, AT (B)(6) - ASSISTED LIVING. ON (B)(6) IN THE LATE AFTERNOON (TWO DIFFERENT P.M. TIMES WERE INDICATED), AN APPROXIMATELY (B)(6) RESIDENT REQUIRED TREATMENT WITH A DEFIBRILLATOR. A "CPR/AED TRAINED STAFF MEMBER WAS UNABLE TO MAKE SKINTACT AED ELECTRODES CONNECT TO WELCH ALLYN AED 10 MACHINE. CLIP WAS RESISTANT TO PUSH AND FELT AS IF ENDS WERE NOT MATCHED." "OUR STAFF PERFORMED CPR AND EMS DID PROVIDE DEFIBRILLATION VERY QUICKLY AFTER ARRIVAL" (WITH THEIR DEFIBRILLATOR). THE ELECTRODE WAS THROWN AWAY. THE DEFIBRILLATOR WILL BE MADE AVAILABLE FOR FURTHER ANALYSIS. THE PATIENT "PASSED AWAY SOMETIME DURING THE NIGHT OF (B)(6) IN ICU AT OUR LOCAL HOSPITAL." "HIS DEATH WAS CAUSED BY COMPLICATIONS RELATED TO A CARDIAC ARREST (WE BELIEVE, BUT AGAIN DO NOT HAVE MEDICAL RECORDS). (...) THERE IS NO DOUBT IN ANYONE'S MIND THAT THIS WAS A NATURAL CAUSE OF DEATH DESPITE ALL EFFORTS." WE ARE TRYING TO OBTAIN MORE INFORMATION TO DETERMINE WHETHER THE ADVERSE EVENT WAS IN ANY WAY CAUSAL OR CONTRIBUTIVE TO THE PATIENT'S DEATH.

  Patient problems: Death

  MAUDE report 5902787 ↗