X SERIES 610-2241011-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00847946006327), received between Apr 6, 2017 and Sep 17, 2024 — classified as 1 death, 12 malfunctions.

The most frequently reported specific device problem is “Failure to Power Up” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2024Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A 30-YEAR-OLD FEMALE PATIENT, THE DEVICE FAILED TO DISCHARGE. 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: Cardiac Arrest

  MAUDE report 20238749 ↗
• MalfunctionJan 5, 2023Failure to Power Up; Failure to Power Up

  COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE WOULD NOT POWER UP. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16105162 ↗
• MalfunctionSep 3, 2020Unable to Obtain Readings; Output Problem; Unable to Obtain Readings; Output Problem

  COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE'S DEFIB OUTPUT WAS OUT OF SPECIFICATION AND WAS UNABLE TO OBTAIN ECG SIGNAL VIA ELECTRODE PADS. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Patient Involvement

  MAUDE report 10487809 ↗
• MalfunctionMar 17, 2020Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE FAILED THE SYNCHRONIZED CARDIOVERSION TESTING WITH INCORRECT OUTPUT. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Patient Involvement

  MAUDE report 9844711 ↗
• MalfunctionJun 19, 2019Failure of Device to Self-Test; Failure of Device to Self-Test

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

  Patient problems: No Patient Involvement

  MAUDE report 8714173 ↗
• MalfunctionJun 3, 2019Failure to Power Up; Failure to Power Up

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE WOULD NOT FULLY POWER UP. COMPLAINANT INDICATED THAT THE CLINICIAN CALLED FOR 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 Consequences Or Impact To Patient

  MAUDE report 8662249 ↗
• MalfunctionMar 4, 2019Failure to Power Up; Failure to Power Up

  COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE WOULD NOT POWER UP. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Patient Involvement

  MAUDE report 8387756 ↗
• MalfunctionApr 16, 2018Unable to Obtain Readings; Capturing Problem; Unable to Obtain Readings; Capturing Problem

  COMPLAINANT ALLEGED THAT WHILE TREATING A (B)(6) FEMALE PATIENT, THE DEVICE DID NOT DISPLAY AN ECG SIGNAL AND WAS UNABLE TO CAPTURE THE PATIENT'S HEART RHYTHM. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECTS TO THE PATIENT DUE TO THE REPORTED MALFUNCTION. THE PATIENT CONVERTED ON HER OWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7434510 ↗
• MalfunctionNov 29, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DISPLAYED AN "INTERNAL ERROR OCCURRED - SYSTEM RESET REQUIRED" MESSAGE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: No Information

  MAUDE report 7067914 ↗
• MalfunctionNov 13, 2017Failure to Power Up; Failure to Power Up

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE WOULD NOT FULLY POWER UP. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: No Information

  MAUDE report 7025628 ↗
• MalfunctionOct 10, 2017No Display/Image; Unable to Obtain Readings; No Display/Image; Unable to Obtain Readings

  COMPLAINANT ALLEGED THAT WHILE MONITORING A FEMALE PATIENT (AGE UNKNOWN), THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL VIA ELECTRODE PADS AND THE DISPLAY BLANKED OUT. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: No Patient Involvement

  MAUDE report 6937178 ↗
• DeathJul 7, 2017Unable to Obtain Readings; Unable to Obtain Readings

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A (B)(6) FEMALE PATIENT, THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL. COMPLAINANT INDICATED THAT THE CREW BELIEVED THERE WAS A PERIOD OF TIME WHERE THE ELECTRODE PADS WERE NOT PLUGGED INTO THE DEFIBRILLATOR. AFTER THE ELECTRODE PADS WERE PLUGGED INTO THE DEFIBRILLATOR, THE PATIENT SHOWED ASYSTOLE. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

  Patient problems: Death

  MAUDE report 6693032 ↗
• MalfunctionApr 6, 2017Failure to Discharge; Failure to Discharge

  COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE WAS UNABLE TO DISCHARGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Patient Involvement

  MAUDE report 6463515 ↗