LIFEPAK® 15 monitor/defibrillator 99577 (REF 99577-001258)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00883873911600), received between Aug 15, 2018 and Nov 27, 2025 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Failure to Power Up” (4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 27, 2025Failure 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 23664277 ↗
• MalfunctionNov 27, 2025Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE UNABLE TO POWER ON WITH AC OR DC POWER. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23663717 ↗
• MalfunctionNov 13, 2025Failure to Power Up; Failure to Power Up

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23542768 ↗
• MalfunctionApr 3, 2024Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT NONE OF THEIR DEVICE'S BUTTONS ARE WORKING. AS A RESULT, DEFIBRILLATION THERAPY MAY BE 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 19035389 ↗
• MalfunctionNov 10, 2022Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WAS UNABLE TO DELIVER A DEFIBRILLATION SHOCK DURING A PATIENT EVENT. ANOTHER DEVICE WAS USED AND WAS ABLE TO SUCCESSFULLY SHOCK THE PATIENT. IN THIS STATE THE DEVICE WOULD BE INOPERABLE AND DEFIBRILLATION THERAPY WOULD NOT BE AVAILABLE IF NEEDED. THIS ISSUE IS PATIENT RELATED; HOWEVER THE CUSTOMER ADVISED THE PATIENT WAS SUCCESSFULLY RESUSCITATED. THERE WAS NO ADVERSE PATIENT OUTCOME REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15776596 ↗
• MalfunctionOct 5, 2022Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT WHEN PRESSING THE DEVICE'S POWER BUTTON, THE DEVICE'S SCREEN REMAINS BLANK AND ONLY THE DEVICE'S LEDS ILLUMINATE. THIS CAN BE INDICATIVE OF A DEVICE LOCK UP CONDITION AND MAY CAUSE THE DEVICE TO BE UNABLE TO POWER ON TO DELIVER DEFIBRILLATION THERAPY. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15546623 ↗
• InjuryAug 6, 2021Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WAS BEING USED DURING A CODE ON A PATIENT (NO PATIENT INFORMATION AVAILABLE) WHEN CAREGIVERS ATTEMPTED TO DELIVER A SHOCK AT 360JOULES. UPON PUSHING THE SHOCK BUTTON, NOTHING HAPPENED PER REPORT. CAREGIVERS POWERED THE DEVICE OFF AND ON, THEN UTILIZED THE DEVICE AGAIN AND IT PERFORMED PROPERLY. CAREGIVERS DELIVERED APPROPRIATE SHOCK TO PATIENT AND WAS SUCCESSFULLY RESUSCITATED. UPON EVALUATION OF THE CUSTOMER'S DEVICE, THE CUSTOMER OBSERVED AN EVENT CODE LOGGED IN THE DEVICE'S MEMORY. THE EVENT CODE LOGGED IS RELATED TO A POTENTIAL FAILURE OF THE DEVICE TO DELIVER DEFIBRILLATION ENERGY. THE ISSUE IS PATIENT RELATED AND WAS REPORTED TO HAVE DELAYED DEFIBRILLATION FOR AN UNKNOWN TIME.

  Patient problems: Cardiac Arrest

  MAUDE report 12291664 ↗
• MalfunctionAug 4, 2020Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE DISPLAYED ¿ABNORMAL ENERGY DELIVERY¿ WHEN DELIVERING DEFIBRILLATION THERAPY DURING TESTING. IN THIS STATE, THE DEVICE MAY NOT HAVE THE ABILITY TO DELIVER APPROPRIATE DEFIBRILLATION THERAPY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10365696 ↗
• MalfunctionJul 1, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEY WERE USING THEIR DEVICE ON A PATIENT AND THE DISPLAY SHUT OFF AFTER THEY TRIED TO DELIVER DEFIBRILLATION THERAPY. THE CUSTOMER LATER REPORTED THAT THE DEVICE WAS FREEZING DURING THE EVENT. AS A RESULT, DEFIBRILLATION THERAPY MAY HAVE BEEN DELAYED OR UNAVAILABLE, IF NEEDED. THERE WERE NO REPORTS OF ANY ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10221055 ↗
• MalfunctionAug 15, 2018Device Sensing Problem; Device Sensing Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WAS UNABLE TO DETECT THAT A DEFIBRILLATION TEST LOAD WAS CONNECTED TO THEIR DEFIBRILLATION THERAPY CABLE ASSEMBLY. AS A RESULT, DEFIBRILLATION THERAPY MAY NOT BE AVAILABLE TO A PATIENT IF NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7787338 ↗