Internal Handle 1011-0139-03Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00847946022341), received between Aug 21, 2017 and Oct 9, 2023 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Failure to Discharge” (4 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 9, 2023Grounding Malfunction; Grounding Malfunction

  COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE ASSOCIATED DEVICE FAILED LEAKAGE CURRENT TESTING 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 17896367 ↗
• MalfunctionSep 19, 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 HANDLES. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17772383 ↗
• MalfunctionSep 22, 2022Output Problem; Output Problem

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE ASSOCIATED DEVICE'S DEFIB OUTPUT WAS OUT OF SPECIFICATION USING THESE INTERNAL PADDLES. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: Insufficient Information

  MAUDE report 15462945 ↗
• MalfunctionSep 1, 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 PADDLES. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: Insufficient Information

  MAUDE report 15339031 ↗
• MalfunctionSep 1, 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 PADDLES. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: Insufficient Information

  MAUDE report 15337451 ↗
• MalfunctionMay 4, 2022Grounding Malfunction; Grounding Malfunction

  COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE ASSOCIATED DEVICE FAILED THE EARTH GROUND RESISTANCE TEST USING THESE PADDLES. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14280250 ↗
• MalfunctionJan 30, 2018Failure to Discharge; Failure to Discharge

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A (B)(6) MALE PATIENT, THE ASSOCIATED DEFIBRILLATOR WAS UNABLE TO DISCHARGE USING THESE INTERNAL HANDLES. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: No Information

  MAUDE report 7228512 ↗
• MalfunctionJan 18, 2018Failure to Discharge; Failure to Discharge

  COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE ASSOCIATED DEFIBRILLATOR INTERMITTENTLY 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 7203525 ↗
• MalfunctionOct 5, 2017Energy Output Problem; Energy Output Problem

  COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, 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 6918775 ↗
• MalfunctionAug 21, 2017Failure to Discharge; Failure to Discharge

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A TRAUMA ARREST PATIENT (AGE & GENDER UNKNOWN), THE ASSOCIATED DEFIBRILLATOR FAILED TO DISCHARGE USING THESE 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. PLEASE REFERENCE MEDWATCH REPORT 1220908-2017-01932 FOR A SIMILAR EVENT REPORTED FROM THE SAME CUSTOMER.

  Patient problems: No Information

  MAUDE report 6807154 ↗
• MalfunctionAug 21, 2017Failure to Discharge; Failure to Discharge

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A TRAUMA ARREST PATIENT (AGE & GENDER UNKNOWN), THE ASSOCIATED DEFIBRILLATOR FAILED TO DISCHARGE USING THESE 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. PLEASE REFERENCE MEDWATCH REPORT 1220908-2017-01973 FOR A SIMILAR EVENT REPORTED FROM THE SAME CUSTOMER.

  Patient problems: No Information

  MAUDE report 6807148 ↗