LIFEPAK® 15 monitor/defibrillator 99577 (REF 99577-001252)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00883873911679), received between Nov 30, 2018 and Jun 6, 2019 — classified as 1 death, 4 malfunctions.

The most frequently reported specific device problem is “Unexpected Shutdown” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 6, 2019Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE POWERED OFF BY ITSELF DURING A PATIENT EVENT. THIS ISSUE OCCURRED WHEN THE 12 LEAD BUTTON WAS PRESSED. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO REPORT OF AN ADVERSE PATIENT OUTCOME. PHYSIO-CONTROL CONTACTED THE CUSTOMER IN ORDER TO OBTAIN ADDITIONAL INFORMATION ABOUT BOTH THE PATIENT AND THE EVENT, HOWEVER, THE CUSTOMER ADVISED THAT NO FURTHER DETAILS ARE AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8676931 ↗
• MalfunctionMay 31, 2019Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT WHEN ATTEMPTING TO COMPLETE DAILY TESTING ON THEIR DEVICE, THE SERVICE INDICATOR ILLUMINATED AND THE DEVICE POWERED ITSELF OFF. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 8661029 ↗
• MalfunctionMar 4, 2019Unexpected Shutdown; Unexpected Shutdown

  A THIRD-PARTY SERVICE AGENT CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR CUSTOMER'S DEVICE HAD UNEXPECTEDLY POWERED OFF TWICE DURING RESUSCITATION OF A PATIENT. PHYSIO-CONTROL CONTACTED THE CUSTOMER IN ORDER TO OBTAIN ADDITIONAL INFORMATION ABOUT THE PATIENT AND EVENT; HOWEVER, NO RESPONSE WAS RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8388206 ↗
• MalfunctionFeb 5, 2019Device Sensing Problem; Device Sensing Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEY WERE USING THIS DEVICE ON A PATIENT AND HAD A 4-LEAD ECG CABLE CONNECTED TO THE PATIENT. THE DEVICE WAS DISPLAYING ONLY DASHED LINES FOR THE PATIENT'S RHYTHM, SO THEY CONNECTED DEFIBRILLATION ELECTRODES TO THE PATIENT AND ATTEMPTED TO GET AN ECG RHYTHM THROUGH THE DEVICE'S PADDLES LEAD. THE DEVICE STILL WOULDN'T SHOW THE PATIENT'S RHYTHM. THE CUSTOMER PRESSED THE ANALYZE BUTTON AND THE DEVICE RETURNED A "NO SHOCK ADVISED " MESSAGE. THE DEVICE THEN SHOWED THE PATIENT WAS IN A NORMAL SINUS RHYTHM THROUGH THE PADDLES LEAD ECG. AS A RESULT, DEFIBRILLATION THERAPY MAY HAVE BEEN DELAYED OR UNAVAILABLE, IF IT WAS NEEDED. THE CUSTOMER CONFIRMED THAT THE PATIENT, A (B)(6) MALE, SURVIVED THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8309047 ↗
• DeathNov 30, 2018Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEY WERE USING THIS DEVICE ON A PATIENT AND HAD AN ISSUE WITH THE AED FUNCTION OF THE DEVICE. THE DEVICE RETURNED A "NO SHOCK ADVISED" MESSAGE TO THE USER TWO TO THREE TIMES BEFORE ADVISING THE USER TO SHOCK THE PATIENT. THE USER DELIVERED A SHOCK TO THE PATIENT AND THEN THE DEVICE WENT BACK TO THE "NO SHOCK ADVISED" MESSAGE. THE CUSTOMER IS UNSURE IF THE DEVICE RETURNED THE CORRECT SHOCK ADVISORY MESSAGES DURING THE EVENT. THE PATIENT INVOLVED IN THIS EVENT, AN (B)(6) MALE, IS DECEASED. NO FURTHER PATIENT INFORMATION WAS PROVIDED.

  Patient problems: Death

  MAUDE report 8121247 ↗