LIFEPAK® 15 monitor/defibrillator 99577 (REF 99577-000063)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00883873979327), received between Jun 9, 2020 and Oct 31, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 31, 2025Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE TURNS ITSELF OFF WHEN TRYING TO BOOT UP THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23436318 ↗
• MalfunctionDec 19, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE IS NOT COMPLETING THE INITIAL BOOT-UP CYCLE. IN THIS STATE THE DEVICE WOULD BE INOPERABLE AND 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 18356359 ↗
• MalfunctionOct 30, 2023Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NOT COMPLETE ITS INITIAL BOOT-UP CYCLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18031771 ↗
• MalfunctionOct 23, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED STRYKER TO THEIR DEVICE DISPLAYED A BLANK SCREEN, WHILE ALSO EXPERIENCING REPEATED BOOT CYCLES. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY, IF NEEDED. THERE WAS NO PATIENT INVOLVEMENT IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17990688 ↗
• MalfunctionSep 22, 2023Failure to Power Up; Failure of Device to Self-Test; Failure to Power Up; Failure of Device to Self-Test

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NOT COMPLETE NOT COMPLETE ITS INITIAL BOOT-UP CYCLE. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY, IF NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17803341 ↗
• MalfunctionJun 28, 2023Electrical /Electronic Property Problem; Failure to Power Up; Electrical /Electronic Property Problem; Failure to Power Up

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE FAILED TO DELIVER DEFIBRILLATION THERAPY AND WOULD NOT POWER ON. IN THIS STATE, THE DEVICE MAY BE UNABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THIS ISSUE IS PATIENT RELATED; HOWEVER, NO ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17215169 ↗
• MalfunctionJun 13, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT WHEN ATTEMPTING TO POWER ON THEIR DEVICE IT WOULD NOT COMPLETE A BOOT CYCLE. IN THIS STATE, THE DEVICE WOULD BE INOPERABLE AND 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 14676145 ↗
• MalfunctionJun 9, 2020Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE FAILED TO PROVIDE ENERGY WHEN SHOCK WAS REQUESTED. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE EVENT REPORTED. IT WAS REPORTED A BACKUP DEVICE WAS USED AND THE PATIENT SURVIVED THE EVENT.

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

  MAUDE report 10133901 ↗