M SERIES BIPHASIC 40010011100163011Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00847946002916), received between Aug 13, 2015 and Jun 5, 2020 — classified as 1 death, 8 malfunctions.

The most frequently reported specific device problem is “Failure to Power Up” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 5, 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 10124034 ↗
• MalfunctionDec 11, 2019Failure to Power Up; Failure to Power Up

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

  Patient problems: No Patient Involvement

  MAUDE report 9453584 ↗
• MalfunctionOct 17, 2019Pacing Problem; Pacing Problem

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

  Patient problems: No Patient Involvement

  MAUDE report 9204545 ↗
• DeathMar 14, 2019Unable to Obtain Readings; Unable to Obtain Readings

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A (B)(6) YEAR-OLD MALE PATIENT, THE DEVICE DISPLAYED A "DEFIB PAD SHORT" MESSAGE. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE AND ELECTRODE PADS TO CONTINUE TREATING THE PATIENT AND RECEIVED THE SAME ERROR. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED. PLEASE REFERENCE MEDWATCH REPORT 1220908-2019-00648 FOR THE ANOTHER DEFIBRILLATOR USED IN THE EVENT.

  Patient problems: Death

  MAUDE report 8420085 ↗
• MalfunctionJun 1, 2018No Display/Image; No Display/Image

  COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE'S DISPLAY WAS DISTORTED AND NO CLINICAL INFORMATION COULD BE SEEN. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Patient Involvement

  MAUDE report 7562475 ↗
• MalfunctionNov 27, 2017Failure to Power Up; Failure to Power Up

  COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE WAS UNABLE TO POWER ON. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Patient Involvement

  MAUDE report 7060992 ↗
• MalfunctionOct 10, 2017Energy Output Problem; Energy Output Problem

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

  Patient problems: No Patient Involvement

  MAUDE report 6935615 ↗
• MalfunctionMar 30, 2017Loss of Power; Loss of Power

  COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE INAPPROPRIATELY SHUT DOWN. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Patient Involvement

  MAUDE report 6446805 ↗
• MalfunctionAug 13, 2015Failure to Discharge

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A MALE PATIENT (AGE 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 Known Impact Or Consequence To Patient

  MAUDE report 5008514 ↗