PROPAQ MD 320-2461312-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00847946020224), received between May 31, 2017 and Oct 23, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Failure to Power Up” (3 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 23, 2025Failure 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 23367320 ↗
• MalfunctionFeb 1, 2024Failure 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 18621571 ↗
• MalfunctionOct 28, 2022Unexpected Shutdown; Unexpected Shutdown

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO MONITOR 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 15691875 ↗
• MalfunctionMay 18, 2022Reset Problem; Reset Problem

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO MONITOR A PATIENT (AGE & GENDER UNKNOWN) DURING TRANSPORT, THE DEVICE RESTART/REBOOT ITSELF MULTIPLE TIMES. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14428899 ↗
• MalfunctionFeb 1, 2021Failure 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11258561 ↗
• MalfunctionNov 11, 2020Pacing Problem; Defibrillation/Stimulation Problem; Pacing Problem; Defibrillation/Stimulation Problem

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DISPLAYED A "PACE DEFIB DEVICE FAILURE" 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 10825003 ↗
• MalfunctionNov 19, 2019Failure to Power Up; Unexpected Shutdown; Failure to Power Up; Unexpected Shutdown

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE INAPPROPRIATELY SHUT DOWN AND WOULD NOT POWER UP. 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 9343361 ↗
• MalfunctionJun 20, 2019Unable to Obtain Readings; Unable to Obtain Readings

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO MONITOR A PATIENT (AGE & GENDER UNKNOWN) DURING TRANSPORT, 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 Consequences Or Impact To Patient

  MAUDE report 8717526 ↗
• MalfunctionAug 28, 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 PACER FUNCTION. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Patient Involvement

  MAUDE report 7823663 ↗
• MalfunctionJun 29, 2017Loss of Power; Loss of Power

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN) DURING TRANSPORT, THE DEVICE RESTARTED/REBOOTED ITSELF. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: No Information

  MAUDE report 6676574 ↗
• MalfunctionMay 31, 2017Loss of Power; Loss of Power

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A MALE PATIENT (AGE 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 6602641 ↗