X SERIES 610-2231010-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00847946004330), received between May 22, 2017 and Sep 18, 2026 — classified as 4 deaths, 16 malfunctions.

The most frequently reported specific device problem is “Failure of Device to Self-Test” (3 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Failure to Power Up

  COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE WOULD INTERMITTENTLY NOT POWER UP.COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50818816 ↗
• MalfunctionMar 18, 2025Unable to Obtain Readings; Unable to Obtain Readings

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO CARDIOVERT A 40-YEAR-OLD FEMALE PATIENT, THE DEVICE WAS UNABLE TO DETECT THE ATTACHED ELECTRODE PADS. 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 21632650 ↗
• MalfunctionAug 23, 2023Unexpected Shutdown; Unexpected Shutdown

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO MONITOR A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE INAPPROPRIATELY SHUT DOWN. 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 17602283 ↗
• MalfunctionOct 26, 2022Failure of Device to Self-Test; Failure of Device to Self-Test

  COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE FAILED SELF-TEST FOR PACER FUNCTION. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: Insufficient Information

  MAUDE report 15673362 ↗
• MalfunctionJun 7, 2022Failure of Device to Self-Test; Failure of Device to Self-Test

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14622688 ↗
• MalfunctionFeb 4, 2022Pacing Problem; Defibrillation/Stimulation Problem; Pacing Problem; Defibrillation/Stimulation Problem

  COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE DISPLAYED A "PACE DEFIB DEVICE FAILURE" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13455539 ↗
• MalfunctionSep 29, 2021Reset Problem; Reset Problem

  COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE RESTART/REBOOT ITSELF MULTIPLE TIMES. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12548207 ↗
• MalfunctionJul 30, 2021Electrical Shorting; Electrical Shorting

  COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE DISPLAYED A "SHORT DETECTED" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12253872 ↗
• MalfunctionJul 6, 2021No Display/Image; Use of Device Problem; No Display/Image; Use of Device Problem

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO MONITOR A PATIENT (AGE & GENDER UNKNOWN) THE DEVICE POWERED UP IN THE INCORRECT MODE AND THE SCREEN TURNED COMPLETELY WHITE AND WAS ILLEGIBLE. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: Insufficient Information

  MAUDE report 12124274 ↗
• MalfunctionMar 27, 2021Unexpected Shutdown; Unexpected Shutdown

  COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE INAPPROPRIATELY SHUT DOWN.COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11580005 ↗
• DeathDec 23, 2020Reset Problem; Reset Problem

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A (B)(6) FEMALE PATIENT, THE DEVICE DISPLAYED AN "INTERNAL ERROR OCCURRED - SYSTEM RESET REQUIRED" MESSAGE. COMPLAINANT INDICATED THE DEVICE DID CHARGE AND DELIVERED THE SELECTED ENERGY 6 TIMES. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

  Patient problems: Death

  MAUDE report 11068628 ↗
• MalfunctionJan 24, 2020Failure 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 FOR DEFIB FUNCTION. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Patient Involvement

  MAUDE report 9629312 ↗
• MalfunctionDec 3, 2019Reset Problem; Reset Problem

  COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE RESTART/REBOOT ITSELF. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Patient Involvement

  MAUDE report 9402300 ↗
• MalfunctionAug 15, 2019Use of Device Problem; Use of Device Problem

  THE COMPLAINANT ALLEGED WHILE DEFIBRILLATING A PATIENT (AGE AND GENDER UNKNOWN), THE DEVICE DISPLAYED A "DO NOT USE ICON" MESSAGE. THIS IS THE ONLY INFORMATION AVAILABLE. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: No Patient Involvement

  MAUDE report 8898995 ↗
• MalfunctionJul 11, 2019No Display/Image; No Display/Image

  COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE'S SCREEN TURNED COMPLETELY WHITE AND WAS ILLEGIBLE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Patient Involvement

  MAUDE report 8781012 ↗
• MalfunctionDec 21, 2018Failure to Power Up; Unable to Obtain Readings; Use of Device Problem; Failure to Power Up; Unable to Obtain Readings; Use of Device Problem

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO MONITOR A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DISPLAYED AN UNKNOWN ERROR MESSAGE. NO FURTHER INFORMATION WAS PROVIDED. ALSO, THE DEVICE WOULD INTERMITTENTLY NOT 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 8191126 ↗
• DeathDec 10, 2018Unable to Obtain Readings; Unable to Obtain Readings

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A (B)(6) PATIENT (GENDER UNKNOWN) IN CRITICAL ARREST, THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL VIA ELECTRODE PADS. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

  Patient problems: Death

  MAUDE report 8147657 ↗
• DeathMay 15, 2018Delayed Charge Time; Device Operational Issue; Delayed Charge Time; Device Operational Issue

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO MONITOR A (B)(6) MALE PATIENT, THE DEVICE DELAYED TO CHARGE AND INTERNALLY DUMPED THE ENERGY AFTER CHARGING UP TO DEFIBRILLATE THE PATIENT. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED, HOWEVER THEY BELIEVE IT WAS NOT A RESULT OF THE REPORTED MALFUNCTION.

  Patient problems: Death

  MAUDE report 7514637 ↗
• MalfunctionSep 26, 2017No Display/Image; No Display/Image

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A FEMALE PATIENT (AGE UNKNOWN), THE DEVICE'S SCREEN TURNED COMPLETELY BLACK AND NO CLINICAL INFORMATION COULD BE SEEN. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: No Information

  MAUDE report 6895720 ↗
• DeathMay 22, 2017Failure to Discharge; Failure to Discharge

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A PATIENT (AGE & GENDER UNKNOWN), AFTER THREE DISCHARGES, ON THE FOURTH ATTEMPT THE DEVICE FAILED TO DISCHARGE. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

  Patient problems: Cardiac Arrest; Death

  MAUDE report 6583255 ↗