X SERIES 610-2241411-01-66Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00847946018238), received between Oct 27, 2017 and Aug 1, 2019 — classified as 2 deaths, 3 malfunctions.

The most frequently reported specific device problem is “Failure of Device to Self-Test” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 1, 2019Failure 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 AND PACER FUNCTION. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Patient Involvement

  MAUDE report 8851497 ↗
• MalfunctionSep 4, 2018Failure of Device to Self-Test; Failure of Device to Self-Test

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A (B)(6) MALE PATIENT DURING CARDIAC ARREST, AFTER ONE SUCCESSFUL SHOCK, THE PATIENT WAS NOTED TO BE IN VENTRICULAR TACHYCARDIA AND ON THE ATTEMPT TO SHOCK THE DEVICE DISPLAYED A "DEFIB/PACER FAILURE" MESSAGE. THE DEVICE WAS RE-STARTED IN AN ATTEMPT TO CLEAR THE MESSAGE AND THE DEVICE FAILED THE POWER ON SELF-TEST FOR DEFIB AND PACER FUNCTIONS. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PATIENT. HOWEVER THE RHYTHM RETURNED TO PULSELESS ELECTRICAL ACTIVITY. COMPLAINANT INDICATED THAT DUE TO THE PATIENT CURRENT CLINICAL STATUS THE PATIENT'S FAMILY DISCONTINUED EFFORTS TO RESUSCITATE AND THE PATIENT WAS TRANSITIONED TO COMFORT MEASURE ONLY.

  Patient problems: No Information

  MAUDE report 7843533 ↗
• DeathJun 5, 2018Failure to Charge; Charging Problem; Failure to Charge; Charging Problem

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A (B)(6) MALE PATIENT, THE DEVICE FAILED TO CHARGE TO SET ENERGY ON THE FIRST ATTEMPT TO CHARGE, BUT SUCCESSFULLY CHARGED AND DELIVERED A SHOCK ON THE SECOND ATTEMPT. THE DEVICE THEN FAILED TO CHARGE TO SET ENERGY AGAIN ON THE THIRD ATTEMPT. COMPLAINANT INDICATED THAT THE DEVICE WAS INTERMITTENTLY TAKING AN EXTENDED TIME TO CHARGE. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED AN AED DEVICE TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

  Patient problems: Death

  MAUDE report 7569164 ↗
• MalfunctionMar 12, 2018Loss of Power; Loss of Power

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO MONITOR A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE INAPPROPRIATELY SHUT DOWN. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: No Information

  MAUDE report 7330844 ↗
• DeathOct 27, 2017Unable to Obtain Readings; Unable to Obtain Readings

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A (B)(6) YEAR OLD FEMALE PATIENT IN CARDIAC ARREST, THE DEVICE WAS UNABLE TO CHANGE TO PADS MODE TO OBTAIN AN ECG SIGNAL. COMPLAINANT INDICATED THAT DURING SUBSEQUENT TESTING WITH A SIMULATOR, THE MALFUNCTION WAS NOT DUPLICATED. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED, HOWEVER IT WAS NOT A RESULT OF THE REPORTED MALFUNCTION.

  Patient problems: Death

  MAUDE report 6984486 ↗