PROPAQ MD 310-2421302-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00847946017682), received between Aug 3, 2015 and Dec 9, 2020 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Failure of Device to Self-Test” (5 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 9, 2020Unexpected Shutdown; Unexpected Shutdown

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TRANSPORT A PATIENT VIA HELICOPTER (AGE & GENDER UNKNOWN), ON THE FLIGHT DECK OF THE USS THEODORE ROOSEVELT, THE DEVICE INAPPROPRIATELY SHUT DOWN. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED A SECOND DEVICE (SERIAL NUMBER (B)(4) ) TO CONTINUE TREATING THE PATIENT AND THE DEVICE ALSO INAPPROPRIATELY SHUT DOWN. A THIRD DEVICE (SERIAL NUMBER UNKNOWN) WAS OBTAINED AND THE THIRD DEVICE ALSO INAPPROPRIATELY SHUT DOWN. THE COMPLAINANT INDICATED THAT THE SHIP THEN SECURED THE SPS-48 RADAR, UPON SECURING THE RADAR, THE DEVICES CONTIINUED WORKING PROPERLY. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: No Information

  MAUDE report 10979554 ↗
• MalfunctionJul 13, 2020Reset Problem; Noise, Audible; Reset Problem; Noise, Audible

  COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, A POPPING SOUND WAS HEARD AND AN "INTERNAL ERROR OCCURRED-SYSTEM RESET REQUIRED" MESSAGE WAS SEEN. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Patient Involvement

  MAUDE report 10267118 ↗
• MalfunctionJul 13, 2020Output below Specifications; Output below Specifications

  COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, 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 10267081 ↗
• MalfunctionJul 13, 2020Pacing Problem; Pacing Problem

  COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE DID NOT HAVE PACER OUTPUT. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Patient Involvement

  MAUDE report 10265975 ↗
• MalfunctionJun 3, 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 FOR DEFIB FUNCTION. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Patient Involvement

  MAUDE report 10116221 ↗
• MalfunctionApr 6, 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 9930625 ↗
• MalfunctionMar 17, 2020Output above Specifications; Output above Specifications

  COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING 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 9843635 ↗
• MalfunctionMar 17, 2020Accessory Incompatible; Accessory Incompatible

  COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE WAS UNABLE TO DETECT THE ATTACHED EXTERNAL PADDLES. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Patient Involvement

  MAUDE report 9843372 ↗
• MalfunctionAug 31, 2018Failure of Device to Self-Test; Failure of Device to Self-Test

  COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, 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 7837336 ↗
• MalfunctionApr 30, 2018Failure 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 7472872 ↗
• MalfunctionApr 30, 2018Failure of Device to Self-Test; Failure of Device to Self-Test

  COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, 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 7471844 ↗
• MalfunctionMar 2, 2018Device Operational Issue; Device Operational Issue

  COMPLAINANT ALLEGED THAT DURING BIOMED TESTING THE DEVICE'S DEFIB OUTPUT WAS INCORRECT. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Patient Involvement

  MAUDE report 7310509 ↗
• MalfunctionSep 25, 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 6889762 ↗
• MalfunctionMay 22, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE DISPLAYED A "INTERNAL ERROR OCCURRED - SYSTEM RESET REQUIRED" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Patient Involvement

  MAUDE report 6582665 ↗
• MalfunctionAug 3, 2015Device Operates Differently Than Expected

  COMPLAINANT ALLEGED THAT DURING BIOMED TESTING THE DEVICE POWER CYCLED INAPPROPRIATELY. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Patient Involvement

  MAUDE report 4992388 ↗