Internal Handle 1011-0139-04Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00847946022358), received between Jan 31, 2019 and Sep 29, 2022 — classified as 1 death, 5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2022Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE ASSOCIATED DEVICE 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 15501442 ↗
• DeathMar 8, 2019Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE INTERNAL HANDLES FAILED TO DISCHARGE. COMPLAINANT INDICATED THAT THE ED TEAM HAD OPENED THE CHEST OF A TRAUMA PATIENT WITH MULTIPLE GUN-SHOT WOUNDS. THE PATIENT WAS IN VENTRICULAR FIBRILLATION. CARDIAC MASSAGE WAS ONGOING, ALONG WITH MASSIVE BLOOD TRANSFUSION. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER SET OF INTERNAL HANDLES TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

  Patient problems: Death; No Consequences Or Impact To Patient

  MAUDE report 8404977 ↗
• MalfunctionFeb 20, 2019Failure to Deliver Energy; Failure to Deliver Energy

  COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, 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 8355001 ↗
• MalfunctionFeb 20, 2019Failure to Deliver Energy; Failure to Deliver Energy

  COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, 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 8354895 ↗
• MalfunctionJan 31, 2019Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE ASSOCIATED DEFIBRILLATOR FAILED TO DISCHARGE USING THESE ATTACHED INTERNAL HANDLES. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER SET OF 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: No Information

  MAUDE report 8293743 ↗
• 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 8293742 ↗