LIFEPAK® 15 monitor/defibrillator 99577 (REF 99577-001939)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00883873871874), received between Jun 7, 2018 and May 23, 2024 — classified as 13 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 23, 2024Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NOT POWER ON. IN THIS STATE THE DEVICE WOULD BE INOPERABLE AND DEFIBRILLATION THERAPY WOULD NOT BE AVAILABLE IF NEEDED. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19382217 ↗
• MalfunctionMay 16, 2024Energy Output Problem; Energy Output Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE HAD AN EVENT CODE LOGGED IN ITS MEMORY AND ALSO DELIVERED A LOWER ENERGY SHOCK THAN THE LEVEL SELECTED. THE EVENT CODE LOGGED IN THE DEVICE'S MEMORY MAY BE ASSOCIATED WITH A PARTIAL LOSS OF DEFIBRILLATOR OUTPUT ENERGY DUE TO A LOSS OF THE NEGATIVE PORTION OF THE BIPHASIC OUTPUT WAVEFORM. THIS WOULD RESULT IN A MONOPHASIC SHOCK BEING DELIVERED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19335003 ↗
• MalfunctionApr 18, 2024Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  THE 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 TO DELIVER ENERGY. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED TO THE REPORTED EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 19135809 ↗
• MalfunctionApr 11, 2024Failure to Power Up; Key or Button Unresponsive/not Working; Failure to Power Up; Key or Button Unresponsive/not Working

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THE ON BUTTON OF THEIR DEVICE WOULD WORK INTERMITTENTLY. THIS ISSUE MAY PREVENT THE DEVICE FROM PROVIDING THERAPY IF IT WERE NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19085769 ↗
• MalfunctionDec 12, 2023Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NOT POWER ON. 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 18312608 ↗
• MalfunctionDec 1, 2023Fracture; Mechanical Problem; Fracture; Mechanical Problem

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THE THERAPY CABLE HAD A BROKEN PIN. AS A RESULT, DEFIBRILLATION 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 18244539 ↗
• MalfunctionNov 6, 2023Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE'S ON/OFF BUTTON WAS NOT RESPONDING. IN THIS STATE THE DEVICE WOULD BE INOPERABLE AND DEFIBRILLATION THERAPY WOULD NOT BE AVAILABLE IF NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18081195 ↗
• MalfunctionSep 15, 2023Unexpected Shutdown; Unexpected Shutdown

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WAS NOT COMPLETING BOOT-UP CYCLE DURING INITIAL 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 17753909 ↗
• MalfunctionNov 10, 2022Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  A STRYKER SERVICE REPRESENTATIVE WAS PERFORMING ROUTINE PREVENTATIVE MAINTENANCE ON THE CUSTOMER¿S DEVICE AND OBSERVED AN EVENT CODE LOGGED IN THE DEVICE MEMORY WHICH IS RELATED TO A POTENTIAL ISSUE OF THE DEVICE TO DELIVER DEFIBRILLATION ENERGY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15770445 ↗
• MalfunctionApr 26, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT AN EVENT CODE IS LOGGED IN THE MEMORY OF THEIR DEVICE. THE EVENT CODE LOGGED IN ITS MEMORY IS INDICATIVE OF 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. DURING EVALUATION, PHYSIO-CONTROL VERIFIED THE CUSTOMER REPORTED ISSUE AND ALSO OBSERVED ANOTHER EVENT CODE LOGGED IN THE DEVICE'S MEMORY WHICH IS RELATED TO A POTENTIAL FAILURE OF THE DEVICE TO DELIVER DEFIBRILLATION ENERGY. THERE WAS NO REPORT OF PATIENT INVOLVEMENT ASSOCIATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11725409 ↗
• MalfunctionOct 30, 2019Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WAS UNABLE TO DELIVER A DEFIBRILLATION SHOCK DURING A PATIENT EVENT. THE CUSTOMER ADVISED THAT ANOTHER DEFIBRILLATOR WAS IMMEDIATELY OBTAINED TO DELIVER THE SHOCK. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE PATIENT OUTCOME REPORTED. NO FURTHER DETAILS WERE PROVIDED BY THE CUSTOMER. PHYSIO-CONTROL MADE MULTIPLE ATTEMPTS TO CONTACT THE CUSTOMER IN ORDER TO OBTAIN ADDITIONAL INFORMATION ABOUT BOTH THE PATIENT AND THE EVENT, BUT HAS BEEN UNSUCCESSFUL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9257156 ↗
• MalfunctionJun 21, 2019Connection Problem; Connection Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEY WERE USING THIS DEVICE ON A PATIENT WITH INTERNAL PADDLES AND THEY DELIVERED 3 TO 4 SHOCKS TO THE PATIENT AND THEN THE DEVICE DISPLAYED A "CONNECT ELECTRODES" MESSAGE. AS A RESULT, DEFIBRILLATION THERAPY MAY HAVE BEEN DELAYED OR UNAVAILABLE, IF IT WAS NEEDED. THE CUSTOMER SWITCHED TO EXTERNAL HARD PADDLES AFTER A 3 TO 4 MINUTE DELAY AND WAS ABLE TO USE THOSE SUCCESSFULLY ON THE PATIENT. THERE WERE NO REPORTS OF ANY ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE REPORTED ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8722712 ↗
• MalfunctionJun 7, 2018Failure to Deliver Energy; Failure to Deliver Energy

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEY WERE USING THEIR DEVICE AND ATTEMPTED TO DELIVER A SHOCK TO A PATIENT AND THE DEVICE FAILED TO SHOCK. THE CUSTOMER THEN SWITCHED TO A BACK-UP DEVICE. 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. NO RESPONSE HAS BEEN RECEIVED FROM THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7579448 ↗