LIFEPAK® 15 monitor/defibrillator 99577 (REF 99577-000076)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00883873979198), received between Jun 20, 2018 and Aug 24, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Failure to Power Up” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Aug 30, 2024Class IIOpen, Classified

   Due to an out of tolerance tool being used on monitor/defibrillator systems.

   Z-0230-2025 · Root cause: Vendor change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 24, 2023Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WILL NOT POWER ON. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17612258 ↗
• MalfunctionJul 31, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE IS NOT COMPLETING THE BOOT UP PROCESS. WHEN THEY ATTEMPT TO POWER IT ON THE DEVICE WILL START TO TURN ON AND THEN POWER ITSELF OFF AND BACK ON REPEATEDLY. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8846132 ↗
• MalfunctionJun 20, 2018Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE'S POWER BUTTON ON THE MAIN KEYPAD ASSEMBLY HAD A POOR RESPONSE WHEN PRESSED (IN ORDER TO POWER THE DEVICE OFF). ISSUES WITH THE POWER BUTTON COULD ALSO DELAY OR PREVENT THE DEVICE FROM POWERING ON. THERE WERE NO REPORTS OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7623329 ↗
• MalfunctionJun 20, 2018Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE'S ON/OFF BUTTON WAS INTERMITTENTLY NOT RESPONDING WHEN PRESSED. AS A RESULT, DEFIBRILLATION COULD HAVE BEEN DELAYED, OR PREVENTED, IF IT WERE NECESSARY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7621145 ↗