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Skintact DF59NRecalls & reported problems

Leonhard Lang GmbH · Multifunction electrode for defibrillation, pacing, cardioversion, and monitoring · Class 3

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 19005531506432), received between Nov 23, 2016 and Nov 23, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fitting 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

Device problems

  • Fitting Problem1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionNov 23, 2016Fitting Problem; Fitting Problem

    ON (B)(4), WE HAVE BEEN INFORMED ABOUT A MALFUNCTION INVOLVING A DEFIBRILLATION ELECTRODE SET, MODEL SKINTACT DF59N, AND A ZOLL AED PLUS AT (B)(4). THE INITIAL REPORT STATED THE USER HAD DAMAGED THE CONNECTORS OF TWO DEFIBRILLATORS DURING A TRIAL WHEN ATTEMPTING TO CONNECT THE DEFIBRILLATION ELECTRODES TO TWO ZOLL AED PLUS DEFIBRILLATORS. NO PATIENT WAS HARMED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 6123883 ↗

Other Automated External Defibrillators (Non-Wearable) devices

All Automated External Defibrillators (Non-Wearable) devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.