Internal Handle 1011-0141-03Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847946022839), received between Oct 13, 2020 and Sep 28, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Failure to Deliver Shock/Stimulation” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2022Output Problem; Output Problem

  COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE ASSOCIATED DEVICE'S DEFIB OUTPUT WAS OUT OF SPECIFICATION USING THESE INTERNAL HANDLES. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15496805 ↗
• MalfunctionOct 13, 2020Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE ASSOCIATED DEFIBRILLATOR FAILED TO DISCHARGE USING THESE INTERNAL HANDLES. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Patient Involvement

  MAUDE report 10672051 ↗