R SERIES 30000000001130012Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00847946002350), received between Aug 20, 2015 and Sep 28, 2020 — classified as 21 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2020Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE DISPLAYED A "DEFIB FAULT 76" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Patient Involvement

  MAUDE report 10593832 ↗
• MalfunctionSep 1, 2020No Display/Image; No Display/Image

  COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, 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 10479346 ↗
• MalfunctionApr 9, 2020No Display/Image; No Display/Image

  COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE'S DISPLAY SHOWED LINES AND WAS NOT LEGIBLE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Patient Involvement

  MAUDE report 9943005 ↗
• MalfunctionMar 3, 2020No Display/Image; No Display/Image

  COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE POWERED ON WITHOUT DISPLAY. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Patient Involvement

  MAUDE report 9781247 ↗
• MalfunctionJun 14, 2019Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

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

  Patient problems: No Patient Involvement

  MAUDE report 8699384 ↗
• MalfunctionMay 2, 2019No Display/Image; No Display/Image

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

  Patient problems: No Patient Involvement

  MAUDE report 8573154 ↗
• MalfunctionOct 25, 2018Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE DISPLAYED A "DEFIB FAULT 76" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Patient Involvement

  MAUDE report 8005442 ↗
• MalfunctionJun 5, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE DISPLAYED "SYSTEM FAULT 36" AND "SYSTEM FAULT 37" MESSAGES. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Patient Involvement

  MAUDE report 7568863 ↗
• MalfunctionMay 10, 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 THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7504226 ↗
• MalfunctionApr 23, 2018Device Operational Issue; Device Operational Issue

  COMPLAINANT ALLEGED THAT WHILE TRYING TO DEFIBRILLATE A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE WAS UNABLE TO INCREASE ENERGY LEVEL. 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. ADDITIONALLY, DURING SUBSEQUENT BIOMED TESTING, THE DEVICE WOULD INTERMITTENTLY NOT POWER UP.

  Patient problems: No Information

  MAUDE report 7452239 ↗
• MalfunctionMar 5, 2018Failure to Discharge; Failure to Discharge

  COMPLAINANT ALLEGED THAT DURING BIOMED TESTING THE DEVICE WAS INTERMITTENTLY UNABLE TO DISCHARGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Patient Involvement

  MAUDE report 7313161 ↗
• MalfunctionFeb 15, 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. THE CLINICIANS USED ANOTHER SET OF ELECTRODE PADS WITHOUT ANY SUCCESS. AN ATTEMPT WAS MADE TO PACE THE PATIENT, HOWEVER, NO ECG SIGNAL WAS AVAILABLE. COMPLAINANT INDICATED THAT THE CLINICIAN USED ANOTHER SET OF ELECTRODE PADS WITHOUT ANY SUCCESS. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE, USING THE SECOND SET OF PADS, TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

  Patient problems: Death; No Information

  MAUDE report 7272826 ↗
• MalfunctionFeb 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. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Patient Involvement

  MAUDE report 7264495 ↗
• MalfunctionNov 9, 2017Failure 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 7014726 ↗
• MalfunctionSep 13, 2017No Display/Image; No Display/Image

  COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE'S DISPLAY SHOWED VERTICAL LINES AND CLINICAL DATA WAS NOT LEGIBLE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Patient Involvement

  MAUDE report 6862992 ↗
• MalfunctionAug 21, 2017No Display/Image; No Display/Image

  COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE'S DISPLAY BLANKS ON AND OFF. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Patient Involvement

  MAUDE report 6807938 ↗
• MalfunctionAug 2, 2017Connection Problem; Connection Problem

  COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, 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 6760921 ↗
• MalfunctionJul 18, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE DISPLAYED A "SYSTEM FAULT 36" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Patient Involvement

  MAUDE report 6722843 ↗
• MalfunctionJun 26, 2017Failure to Discharge; Failure to Discharge

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

  Patient problems: No Patient Involvement

  MAUDE report 6668024 ↗
• MalfunctionJun 1, 2017Improper Alarm; Improper Alarm

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

  Patient problems: No Patient Involvement

  MAUDE report 6606304 ↗
• MalfunctionAug 20, 2015Device Displays Incorrect Message

  COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE DISPLAYED "DEFIB FAULT 95" AND "DEFIB DISABLED" MESSAGES. COMPLAINANT INDICATED THAT THERE WAS NO PT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Patient Involvement

  MAUDE report 5048858 ↗