LIFEPAK® 15 monitor/defibrillator 99577 (REF 99577-001944)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00883873871829), received between Mar 5, 2019 and Sep 19, 2024 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Defibrillation/Stimulation Problem” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 19, 2024Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE'S ON/OFF BUTTON IS INTERMITTENTLY NOT WORKING. AS A RESULT, THE DEVICE MAY BE UNABLE TO POWER ON TO DELIVER DEFIBRILLATION THERAPY, IF NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20261502 ↗
• MalfunctionJun 26, 2024Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE HAD LOGGED AN EVENT CODE IN THE MEMORY WHICH IS RELATED TO A POTENTIAL ISSUE OF THE DEVICE DELIVER ENERGY. IN THIS STATE, THE DEVICE MAY NOT BE ABLE TO PROVIDE DEFIBRILLATION THERAPY, IF IT WERE NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19616295 ↗
• MalfunctionMar 12, 2024Failure to Power Up; Failure to Power Up

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NOT POWER ON. AS A RESULT, DEFIBRILLATION THERAPY WOULD NOT BE AVAILABLE, IF NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18886540 ↗
• MalfunctionJun 15, 2023Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE LOGGED A CRITICAL EVENT CODE. THE EVENT CODE IS RELATED TO A POTENTIAL ISSUE OF THE DEVICE TO DELIVER ENERGY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17134667 ↗
• MalfunctionMay 9, 2023Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THE SERVICE INDICATOR IS PRESENT AND AN EVENT CODE IS LOGGED IN THE MEMORY OF THEIR DEVICE. THE EVENT CODE LOGGED IN ITS MEMORY INDICATES A DEVICE FAILURE THAT COULD RESULT IN A PARTIAL LOSS OF DEFIBRILLATOR OUTPUT ENERGY DUE TO A LOSS OF THE NEGATIVE PORTION OF THE BIPHASIC OUTPUT WAVEFORM, RESULTING IN A MONOPHASIC SHOCK. THERE WAS NO PATIENT INVOLVEMENT REPORTED DURING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16899600 ↗
• MalfunctionFeb 22, 2023Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE SCREEN WENT BLACK WHEN DEVICE WAS SET TO SHOCK AND LOGGED AN EVENT CODE WHICH IS RELATED TO A POTENTIAL ISSUE OF THE DEVICE TO DELIVER ENERGY. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16421302 ↗
• MalfunctionDec 19, 2022Failure to Deliver Energy; Failure to Deliver Energy

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WAS UNABLE TO DELIVER DEFIBRILLATION THERAPY DURING A PATIENT EVENT. THE CUSTOMER ADVISED THAT THEY ATTEMPTED TO SHOCK THE PATIENT THREE TIMES WITH THE DEFIBRILLATION ELECTRODES AND WAS UNABLE TO. THEY USED THE HARD PADDLES AND WERE ABLE TO SHOCK THE PATIENT BUT FELT THAT THE PATIENT DID NOT RECEIVE THE FULL THERAPY AS THE PATIENT DID NOT MOVE MUCH FROM THE SHOCK. THE PATIENT DID CONVERT TO A NORMAL ECG RHYTHM. IN THIS STATE, DEFIBRILLATION THERAPY MAY BE DELAYED OR PREVENTED FROM BEING DELIVERED TO THE PATIENT IF NEEDED. THIS ISSUE IS PATIENT RELATED; HOWEVER, THERE WAS NO ADVERSE PATIENT OUTCOME REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16011045 ↗
• MalfunctionJul 30, 2020Failure to Charge; Failure to Deliver Shock/Stimulation; Connection Problem; Failure to Charge; Failure to Deliver Shock/Stimulation; Connection Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT A NON-CRITICAL ISSUE WITH THEIR DEVICE. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT. UPON EVALUATION OF THE CUSTOMER'S DEVICE, PHYSIO-CONTROL OBSERVED THAT THE DEVICE WOULD NOT DETECT WHEN ELECTRODES WERE CONNECTED AND WOULD NOT CHARGE OR SHOCK DEFIBRILLATION ENERGY. AS A RESULT, DEFIBRILLATION THERAPY WOULD BE UNAVAILABLE, IF NEEDED.

  Patient problems: No Patient Involvement

  MAUDE report 10347648 ↗
• MalfunctionMar 5, 2019Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE INTERMITTENTLY POWERED OFF BY ITSELF DURING PATIENT USE. THERE WERE NO REPORTS OF ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE REPORTED ISSUE. PHYSIO-CONTROL HAS ATTEMPTED TO CONTACT THE CUSTOMER IN ORDER TO OBTAIN ADDITIONAL INFORMATION ABOUT BOTH THE PATIENT AND THE EVENT; HOWEVER, NO RESPONSE HAS BEEN RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8391882 ↗