Internal Handle 1011-0139-05Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00847946022365), received between Sep 11, 2017 and May 30, 2025 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Failure of Device to Self-Test” (7 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 30, 2025Use of Device Problem; Use of Device Problem

  COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE CAUSED THE ASSOCIATED DEFIBRILLATOR TO DISPLAY A "PADDLE FAULT" MESSAGE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22114855 ↗
• MalfunctionSep 26, 2023Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A PATIENT (AGE & GENDER UNKNOWN), THE ASSOCIATED DEFIBRILLATOR FAILED TO DISCHARGE USING THESE INTERNAL PADDLES. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER SET OF INTERNAL PADDLES TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17819452 ↗
• MalfunctionJul 19, 2023Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE ASSOCIATED DEFIBRILLATOR FAILED TO DISCHARGE USING THESE INTERNAL HANDLES. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17352626 ↗
• MalfunctionDec 13, 2022Failure of Device to Self-Test; Failure of Device to Self-Test

  COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE ASSOCIATED DEFIBRILLATOR FAILED SELF TEST 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 15971859 ↗
• MalfunctionDec 13, 2022Failure of Device to Self-Test; Failure of Device to Self-Test

  COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE ASSOCIATED DEFIBRILLATOR FAILED SELF TEST USING THESE ELECTRODE PADS. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15971837 ↗
• MalfunctionDec 13, 2022Failure of Device to Self-Test; Failure of Device to Self-Test

  COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE FAILED SELF TEST. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15971780 ↗
• MalfunctionDec 13, 2022Failure of Device to Self-Test; Failure of Device to Self-Test

  COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE ASSOCIATED DEFIBRILLATOR FAILED SELF TEST 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 15971015 ↗
• MalfunctionSep 12, 2022High impedance; High impedance

  COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE FAILED FOR HIGH IMPEDANCE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15406584 ↗
• MalfunctionSep 9, 2022Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE ASSOCIATED DEVICE FAILED TO DISCHARGE 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 15392326 ↗
• MalfunctionJun 1, 2022Failure of Device to Self-Test; Failure of Device to Self-Test

  COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE ASSOCIATED DEVICE FAILED SELF TEST USING THESE ATTACHED INTERNAL PADDLES. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14567024 ↗
• MalfunctionApr 11, 2022Failure of Device to Self-Test; Failure of Device to Self-Test

  COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE ASSOCIATED DEFIBRILLATOR FAILED SELF TEST USING THESE INTERNAL HANDLE PADDLES. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: Insufficient Information

  MAUDE report 14076888 ↗
• MalfunctionOct 12, 2021Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE ASSOCIATED DEFIBRILLATOR FAILED TO DISCHARGE USING THESE INTERNAL PADDLES. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12617324 ↗
• MalfunctionMay 26, 2021Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A (B)(6) YEAR OLD MALE PATIENT, THE ASSOCIATED DEFIBRILLATOR FAILED TO DISCHARGE USING THESE ATTACHED INTERNAL HANDLES. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER SET OF INTERNAL HANDLES TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11889077 ↗
• MalfunctionMay 13, 2021Unable to Obtain Readings; Unable to Obtain Readings

  COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE ASSOCIATED DEVICE DISPLAYED "POOR PAD CONTACT" 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 11821064 ↗
• MalfunctionSep 27, 2019Failure of Device to Self-Test; Failure of Device to Self-Test

  COMPLAINANT ALLEGED THAT DURING BIOMED TESTING THE DEVICE FAILED SELF TEST. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Patient Involvement

  MAUDE report 9129722 ↗
• MalfunctionOct 2, 2018Energy Output Problem; Energy Output Problem

  COMPLAINANT ALLEGED THAT DURING TRAINING BY A ZOLL MEDICAL REPRESENTATIVE, THE ASSOCIATED DEFIBRILLATOR'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 Patient Involvement

  MAUDE report 7925357 ↗
• MalfunctionSep 11, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING OPEN CHEST DEFIBRILLATION ON A (B)(6) OLD MALE PATIENT IN VENTRICULAR FIBRILLATION, THE ASSOCIATED DEFIBRILLATOR DISPLAYED A "PADDLE ERROR" MESSAGE USING THESE INTERNAL HANDLES. COMPLAINANT INDICATED THAT THE PATIENT WAS PLACED ON BYPASS AND CONVERTED TO AN ORGANIZED RHYTHM SPONTANEOUSLY. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: No Information

  MAUDE report 6855326 ↗