Skintact DF20NCRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 19005531502915), received between Aug 2, 2017 and Aug 2, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 2, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2017, WE HAVE BEEN INFORMED BY (B)(6), ABOUT A POTENTIAL MALFUNCTION OF A DEFIBRILLATION ELECTRODE DF20 NC AND A LIFEPACK 20 DEFIBRILLATOR AT (B)(6). THE COMPLAINANT REPORTED HE WAS INFORMED BY THE HOSPITAL ABOUT AN INCIDENT INVOLVING DF20 NC, LOT 170406-0979. A PHYSICIAN WANTED TO PERFORM A CARDIOVERSION ON A PATIENT OF MORE THAN 100 KG OF WEIGHT. TWO ATTEMPTS FAILED. THEY REPLACED THE ELECTRODE WITH A QUICKCOMBO ELECTRODE FROM MEDTRONIC. THEY WERE ABLE TO PERFORM THE PROCEDURE THEN. THE DELAY CAUSED BY THE MALFUNCTION CAUSED NO HARM TO THE PATIENT. A SAMPLE OF THE SAME LOT AS THE ELECTRODE INVOLVED IN THE INCIDENT IS BEING SENT TO US. NO FURTHER INFORMATION HAD BEEN MADE AVAILABLE TO US DESPITE REPEATED REQUESTES. IT WAS STATED: "I WILL NOT RECEIVE ANY OTHER ANSWER FROM THE CUSTOMER BEFORE (B)(6). HE LEFT FOR HOLIDAYS."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6759451 ↗