X SERIES 600-2221511-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00847946012717), received between Aug 19, 2015 and Sep 3, 2020 — classified as 27 malfunctions.

The most frequently reported specific device problem is “Failure of Device to Self-Test” (8 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 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2020Failure to Charge; Failure to Charge

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

  Patient problems: No Patient Involvement

  MAUDE report 10488109 ↗
• MalfunctionApr 20, 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. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Patient Involvement

  MAUDE report 9979169 ↗
• MalfunctionDec 16, 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 PACER FUNCTION. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Patient Involvement

  MAUDE report 9475214 ↗
• MalfunctionSep 9, 2019Unable to Obtain Readings; Unable to Obtain Readings

  COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE WAS UNABLE TO DETECT THE ATTACHED MULTI-FUNCTION CABLE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Patient Involvement

  MAUDE report 8976033 ↗
• MalfunctionAug 20, 2019Unintended Power Up; Unintended Power Up

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

  Patient problems: No Patient Involvement

  MAUDE report 8911761 ↗
• MalfunctionJul 17, 2019Unexpected Shutdown; Unexpected Shutdown

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN) THE DEVICE INAPPROPRIATELY SHUT DOWN. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Information

  MAUDE report 8799343 ↗
• MalfunctionJul 13, 2019Failure to Power Up; Failure to Power Up

  COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, 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 8787404 ↗
• MalfunctionJun 25, 2019No Display/Image; No Display/Image

  COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE DISPLAY BLANKED OUT. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Patient Involvement

  MAUDE report 8730496 ↗
• MalfunctionApr 19, 2019Unable to Obtain Readings; Unable to Obtain Readings

  COMPLAINANT ALLEGED THAT WHILE TRANSPORTING AND PACING A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DISPLAYED A "CABLE FAULT" MESSAGE. 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 8532020 ↗
• MalfunctionFeb 15, 2019Failure to Power Up; Unexpected Shutdown; Failure to Power Up; Unexpected Shutdown

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO MONITOR A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE INAPPROPRIATELY SHUTDOWN AND WOULD 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 8344803 ↗
• MalfunctionDec 20, 2018Unexpected Shutdown; Unexpected Shutdown

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT 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 Consequences Or Impact To Patient

  MAUDE report 8186427 ↗
• MalfunctionOct 15, 2018Pacing Problem; Defibrillation/Stimulation Problem; Pacing Problem; Defibrillation/Stimulation Problem

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

  Patient problems: No Patient Involvement

  MAUDE report 7964808 ↗
• MalfunctionJul 12, 2018Intermittent Loss of Power; Intermittent Loss of Power

  COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE WOULD INTERMITTENTLY SHUT ITSELF OFF. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Patient Involvement

  MAUDE report 7681655 ↗
• MalfunctionJun 4, 2018Failure of Device to Self-Test; Failure of Device to Self-Test

  CREATED IN ERROR ET (B)(4) 2018.

  Patient problems: No Patient Involvement

  MAUDE report 7565201 ↗
• MalfunctionMay 31, 2018Failure 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 7556455 ↗
• MalfunctionApr 18, 2018No Display/Image; No Display/Image

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE AND GENDER UNKNOWN), THE DEVICE'S SCREEN BLANKED OUT AND NO CLINICAL INFO COULD BE SEEN. 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: No Information

  MAUDE report 7440500 ↗
• MalfunctionMar 6, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE DISPLAYED A "DEFIB PACER DEVICE FAILURE" MESSAGE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Patient Involvement

  MAUDE report 7317867 ↗
• MalfunctionJan 23, 2018Failure of Device to Self-Test; Failure of Device to Self-Test

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

  Patient problems: No Information

  MAUDE report 7211700 ↗
• MalfunctionAug 30, 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. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Patient Involvement

  MAUDE report 6829824 ↗
• MalfunctionJul 24, 2017Loss of Power; Loss of Power

  COMPLAINANT ALLEGED THAT WHILE MONITORING A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE CONTINUOUSLY RESTARTED/REBOOTED POWER INAPPROPRIATELY. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: No Information

  MAUDE report 6736192 ↗
• MalfunctionJul 6, 2017No Display/Image; No Display/Image

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE'S DISPLAY BLANKED OUT. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: No Information

  MAUDE report 6689487 ↗
• MalfunctionJul 3, 2017Failure 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 6684454 ↗
• MalfunctionMay 4, 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. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Patient Involvement

  MAUDE report 6543501 ↗
• MalfunctionMay 1, 2017Unable to Obtain Readings; Unable to Obtain Readings

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE AND GENDER UNKNOWN) THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL VIA ELECTRODE PADS. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER SET OF ELECTRODES AND THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: No Information

  MAUDE report 6533617 ↗
• MalfunctionMay 1, 2017Loss of Power; Failure of Device to Self-Test; Loss of Power; Failure of Device to Self-Test

  COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE INTERMITTENTLY FAILED SELF-TEST. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Information; No Patient Involvement

  MAUDE report 6533582 ↗