X SERIES 600-2221011-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00847946012649), received between May 19, 2017 and Mar 26, 2020 — classified as 1 death, 21 malfunctions.

The most frequently reported specific device problem is “Unable to Obtain Readings” (6 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2020Unable to Obtain Readings; Unable to Obtain Readings

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO MONITOR A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DISPLAYED AN "ECG DISABLED" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION. PLEASE REFERENCE MEDWATCH REPORT 1220908-2020-00687 FOR A SIMILAR EVENT REPORTED FROM THE SAME CUSTOMER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9885419 ↗
• MalfunctionMar 26, 2020Unable to Obtain Readings; Unable to Obtain Readings

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO MONITOR A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DISPLAYED AN "ECG DISABLED" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION. PLEASE REFERENCE MEDWATCH REPORT NUMBER 1220908-2020-00678 FOR A SIMILAR REPORT FROM THE SAME CUSTOMER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9884262 ↗
• MalfunctionFeb 7, 2020Failure 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 9682068 ↗
• MalfunctionDec 28, 2018Unable to Obtain Readings; Output Problem; Unable to Obtain Readings; Output Problem

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A VSA PATIENT (AGE & GENDER UNKNOWN), THE DEVICE'S CPR FEEDBACK WAS NOT WORKING. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE USING THE SAME ELECTRODE PADS 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 8204555 ↗
• MalfunctionNov 26, 2018Unable to Obtain Readings; Unable to Obtain Readings

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL VIA ELECTRODE PADS. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE USING THE SAME ELECTRODE PADS AND THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL USING THE ELECTRODE PADS. THE CLINICIANS WERE UNABLE TO OBTAIN AN ECG RHYTHM IN A TIMELY MANNER, ONLY ABLE TO OBTAIN A READING AFTER PERFORMING SKIN PREPARATION (SHAVING) AND TRYING A THIRD SET OF ELECTRODE PADS. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: No Information

  MAUDE report 8101259 ↗
• MalfunctionNov 14, 2018Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE'S DEFIB OUTPUT WAS OUT OF SPECIFICATION. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Patient Involvement

  MAUDE report 8069441 ↗
• MalfunctionNov 12, 2018Failure 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 FUNCTIONS. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Patient Involvement

  MAUDE report 8059507 ↗
• MalfunctionSep 18, 2018Failure 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 FUNCTIONS. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Patient Involvement

  MAUDE report 7886370 ↗
• MalfunctionJun 21, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  THE COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE AND GENDER UNKNOWN), THE DEVICE DISPLAYED AN "ECG DISABLED" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: No Information

  MAUDE report 7624477 ↗
• MalfunctionJun 8, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO MONITOR A PATIENT (AGE AND GENDER UNKNOWN), THE DEVICE DISPLAYED AN "ECG DISABLED" 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 7581780 ↗
• MalfunctionMar 20, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DISPLAYED AN "ECG DISABLED" MESSAGE. COMPLAINANT INDICATED THAT THE CLINICIAN TURNED THE DEVICE OFF AND THEN ON TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: No Information

  MAUDE report 7352511 ↗
• MalfunctionMar 12, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE AND GENDER UNKNOWN), THE DEVICE DISPLAYED AN "ECG DISABLED" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION. COMPLAINANT INDICATED THAT DURING SUBSEQUENT TESTING, THE MALFUNCTION WAS NOT DUPLICATED.

  Patient problems: No Information

  MAUDE report 7331518 ↗
• MalfunctionFeb 20, 2018Unable to Obtain Readings; Unable to Obtain Readings

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN) WITH VITAL SIGNS ABSENT, THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL VIA ELECTRODE PADS. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: No Information

  MAUDE report 7283269 ↗
• MalfunctionJan 24, 2018Device Operational Issue; Device Operational Issue

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A PATIENT (AGE AND GENDER UNKNOWN), THE ASSOCIATED DEFIBRILLATOR WAS UNABLE TO DETECT THE ATTACHED ELECTRODE PADS. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: No Information

  MAUDE report 7215451 ↗
• MalfunctionJan 5, 2018Loss of Power; Loss of Power

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN) IN AN ASYSTOLE ARREST, THE DEVICE RESTARTED/REBOOTED. COMPLAINANT INDICATED THAT WHEN THE DEVICE RESTARTED FOR THE SECOND TIME, THEY CONTINUED TREATING THE PATIENT WITH THE DEVICE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: No Information

  MAUDE report 7167656 ↗
• MalfunctionDec 26, 2017Failure 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 PACER AND DEFIB FUNCTIONS. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Patient Involvement

  MAUDE report 7146031 ↗
• MalfunctionDec 21, 2017Unable to Obtain Readings; Unable to Obtain Readings

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN) DURING TRANSPORT, THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL AFTER THE THERAPY CABLE WAS UNPLUGGED AND PLUGGED BACK INTO THE DEVICE. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE AND ASSOCIATED ELECTRODE PADS TO CONTINUE TREATING THE PATIENT. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION. COMPLAINANT INDICATED THAT DURING SUBSEQUENT FUNCTIONAL TESTING, THE MALFUNCTION WAS NOT DUPLICATED.

  Patient problems: No Information

  MAUDE report 7139265 ↗
• DeathDec 1, 2017Failure to Charge; Charging Problem; Failure to Charge; Charging Problem

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE FAILED TO CHARGE, UPON ANOTHER ATTEMPT TO CHARGE, THE DEVICE TOOK AN EXTENDED AMOUNT OF TIME TO CHARGE TO THE SELECTED ENERGY. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

  Patient problems: Death

  MAUDE report 7074684 ↗
• MalfunctionOct 10, 2017Failure to Charge; Delayed Charge Time; Failure to Charge; Delayed Charge Time

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE AND GENDER UNKNOWN), THE DEVICE DELAYED TO CHARGE, THEN DELIVERED ONE SHOCK. THE NEXT ATTEMPT TO CHARGE, THE DEVICE WAS UNABLE TO CHARGE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: No Information

  MAUDE report 6938161 ↗
• MalfunctionAug 23, 2017Failure 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 6812956 ↗
• MalfunctionJul 28, 2017Failure to Discharge; Failure to Discharge

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

  Patient problems: No Patient Involvement

  MAUDE report 6752233 ↗
• MalfunctionMay 19, 2017Device Operational Issue; Device Operational Issue

  COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE WAS UNABLE TO DETECT THE ATTACHED MULTIFUNCTION CABLE, ELECTRODE PADS, AND PADDLES. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Patient Involvement

  MAUDE report 6577989 ↗