LIFEPAK® 15 monitor/defibrillator 99577 (REF 99577-001213)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00883873912836), received between May 1, 2018 and Jun 14, 2024 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Failure to Deliver Energy” (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.

• MalfunctionJun 14, 2024Failure to Deliver Energy; Failure to Deliver Energy

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THERE WAS AN EVENT CODE LOGGED IN THEIR DEVICE'S MEMORY. THE EVENT CODE LOGGED IS RELATED TO A POTENTIAL FAILURE OF THE DEVICE TO DELIVER DEFIBRILLATION ENERGY. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19536914 ↗
• MalfunctionDec 5, 2023Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE HAS LOGGED AN EVENT IN THE MEMORY WHICH CAN BE RELATED TO A FAILURE OF THE DEVICE TO DELIVER DEFIBRILLATION 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 18268040 ↗
• MalfunctionFeb 17, 2021Failure to Deliver Energy

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THERE WAS AN EVENT CODE LOGGED IN THE DEVICE'S MEMORY. THE EVENT CODE LOGGED IS INDICATIVE OF A FAILURE OF THE DEVICE TO DELIVER DEFIBRILLATION ENERGY. AS A RESULT, DEFIBRILLATION THERAPY MAY BE UNAVAILABLE, IF NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11339257 ↗
• MalfunctionFeb 15, 2021Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE'S POWER BUTTON WAS NOT FUNCTIONING. AS A RESULT, DEFIBRILLATION THERAPY MAY HAVE BEEN DELAYED OR UNAVAILABLE, IF NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11327825 ↗
• MalfunctionDec 16, 2019Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE "WOULD NOT POWER ON". THERE WAS NO PATIENT USE REPORTED WITH THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9476541 ↗
• MalfunctionJul 9, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE LOCKED UP AFTER SUCCESSFULLY DELIVERING FOR DEFIBRILLATION ENERGY TO A PATIENT. THE CUSTOMER ADVISED THAT AFTER THEIR DEVICE SUCCESSFULLY SHOCKED THE PATIENT, THEIR DEVICE LOCKED UP. THE USER HAD TO REMOVE THE BATTERIES IN ORDER TO TURN THE DEVICE OFF. AFTER RE-INSTALLING THE BATTERIES THEY WERE ABLE TO POWER THE DEVICE BACK ON. THE PATIENT WAS SUCCESSFULLY CONVERTED DURING THE DEFIBRILLATION SHOCK. THE PATIENT SURVIVED THE EVENT, HOWEVER THE CUSTOMER WAS UNABLE TO PROVIDE ANY FURTHER INFORMATION ON THE EVENT OR THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8774338 ↗
• MalfunctionDec 1, 2018Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER, A BIOMEDICAL ENGINEER, CONTACTED PHYSIO-CONTROL TO REPORT THAT DURING AN EVENT THEIR DEVICE POWERED OFF BY ITSELF MULTIPLE TIMES. THE CUSTOMER ADVISED THAT MEDICAL PERSONNEL WERE IN THE PROCESS OF IMPLANTING AND PROGRAMMING A PACEMAKER WHEN THE REPORTED ISSUE OCCURRED. MEDICAL PERSONNEL STATED THAT THE DEVICE WAS PLUGGED INTO AC POWER AT THE TIME AND HAD TWO FULLY CHARGED BATTERIES INSTALLED. THE DEVICE WAS BEING USED TO MONITOR THE PATIENT'S ECG WAVEFORM DURING THE PROCEDURE. THE CUSTOMER STATED THAT EACH TIME THE DEVICE LOST POWER, MEDICAL PERSONNEL WOULD POWER IT BACK ON, ONLY TO HAVE IT POWER OFF AGAIN. THEY BELIEVED THIS OCCURRED THREE TIMES DURING THE EVENT. NO FURTHER DETAILS WERE PROVIDED. PHYSIO-CONTROL HAS MADE MULTIPLE ATTEMPTS 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 8122349 ↗
• MalfunctionNov 29, 2018Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEY ATTEMPTED TO SHOCK A PATIENT AND THE DEVICE WOULD NOT SHOCK. THIS OCCURRED TWICE DURING THE EVENT. THE CUSTOMER OBTAINED A BACK-UP DEVICE AND REPORTED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT AS A RESULT OF THE REPORTED ISSUE. THE CUSTOMER ADVISED PHYSIO-CONTROL THAT NO FURTHER PATIENT INFORMATION IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8117132 ↗
• MalfunctionMay 1, 2018Failure to Deliver Energy; Failure to Deliver Energy

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WAS USED DURING A PATIENT EVENT AND WOULD NOT SHOCK WHEN THEY WERE ATTEMPTING TO PERFORM A SYNCHRONIZED CARDIOVERSION PROCEDURE THE DEVICE ALSO DISPLAYED THE SERVICE INDICATOR. THE USER POWERED THE DEVICE OFF AND BACK ON AND WAS THEN ABLE TO DELIVER A SHOCK TO THE PATIENT. THERE WERE NO REPORTS OF ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE REPORTED ISSUE. PHYSIO-CONTROL HAS MADE MULTIPLE ATTEMPTS TO CONTACT THE CUSTOMER IN ORDER TO OBTAIN ADDITIONAL INFORMATION ON THE PATIENT; HOWEVER, NO RESPONSE HAS BEEN RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7478675 ↗