Internal Handle 1011-0139-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00847946022334), received between Jun 11, 2018 and Mar 3, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Failure to Deliver Shock/Stimulation” (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.

• MalfunctionMar 3, 2026Grounding Malfunction

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24497185 ↗
• MalfunctionFeb 27, 2025Failure 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 21482729 ↗
• MalfunctionSep 15, 2022Unable to Obtain Readings; Unable to Obtain Readings

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN) THE ASSOCIATED DEVICE WAS UNABLE TO DETECT THESE INTERNAL HANDLES. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER SET OF INTERNAL HANDLES TO CONTINUE TREATING THE PATIENT. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: Insufficient Information

  MAUDE report 15428236 ↗
• MalfunctionAug 10, 2022Output Problem; Output Problem

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

  Patient problems: Insufficient Information

  MAUDE report 15200807 ↗
• MalfunctionAug 10, 2022Output Problem; Output Problem

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A PATIENT (AGE & GENDER UNKNOWN), THE INTERNAL HANDLES DEFIB OUTPUT WAS OUT OF SPECIFICATION. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: Insufficient Information

  MAUDE report 15200303 ↗
• MalfunctionDec 28, 2021Failure 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 13102205 ↗
• MalfunctionMar 19, 2021Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A PATIENT (AGE & GENDER UNKNOWN), THE ASSOCIATED DEVICE FAILED TO DISCHARGE USING THESE INTERNAL HANDLES. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE 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 11529529 ↗
• MalfunctionNov 17, 2020Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO CARDIOVERT A PATIENT (AGE & GENDER UNKNOWN), THESE INTERNAL HANDLES FAILED TO DISCHARGE WHILE ATTACHED TO AN ASSOCIATED DEFIBRILLATOR. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10853736 ↗
• MalfunctionJan 31, 2019Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

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

  Patient problems: No Patient Involvement

  MAUDE report 8293754 ↗
• MalfunctionJun 13, 2018Failure to Discharge; Failure to Discharge

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), 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 7596435 ↗
• MalfunctionJun 11, 2018Failure to Discharge; Failure to Discharge

  COMPLAINANT ALLEGED THAT DURING FUNCTIONAL 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 Patient Involvement

  MAUDE report 7586957 ↗