LIFEPAK® 15 monitor/defibrillator 99577 (REF 99577-001943)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00883873871836), received between Sep 3, 2019 and Jul 1, 2024 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Unexpected Shutdown” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 1, 2024Mechanical Problem; Mechanical Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE'S BATTERY PINS WERE DAMAGED. 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 19641909 ↗
• MalfunctionJan 26, 2024Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  A 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 DELIVER 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 18592373 ↗
• MalfunctionNov 29, 2023Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE HAD AN UNEXPECTED LOSS OF POWER. AS A RESULT, DEFIBRILLATION THERAPY WOULD NOT BE AVAILABLE, IF NEEDED. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18234934 ↗
• MalfunctionFeb 22, 2022Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE UNEXPECTEDLY POWERED OFF. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13579586 ↗
• MalfunctionJan 25, 2022Failure to Deliver Energy; Failure to Deliver Energy

  THE CUSTOMER CONTACTED STRYKER TO REPORT A NON-CRITICAL ISSUE WITH THEIR DEVICE. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT. UPON EVALUATION OF THE CUSTOMER'S DEVICE, STRYKER OBSERVED AN EVENT CODE LOGGED IN THE DEVICE'S MEMORY. THE EVENT CODE LOGGED IN THE DEVICE'S MEMORY IS RELATED TO A FAILURE OF THE DEVICE TO DELIVER DEFIBRILLATION ENERGY. AS A RESULT, DEFIBRILLATION THERAPY MAY BE UNAVAILABLE, IF NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13343354 ↗
• MalfunctionSep 10, 2021Failure to Sense; Failure to Sense

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE DID NOT SHOW AN ECG RHYTHM WITH DEFIBRILLATION ELECTRODES CONNECTED. 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 12456927 ↗
• MalfunctionJun 16, 2021Failure to Charge; Failure to Charge

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEY OBSERVED AN EVENT CODE LOGGED IN THE DEVICE'S MEMORY. THE EVENT CODE LOGGED IS INDICATIVE OF A FAILURE OF THE DEVICE TO CHARGE FOR DEFIBRILLATION ENERGY. AS A RESULT, DEFIBRILLATION THERAPY MAY NOT BE AVAILABLE, IF IT WAS NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12009945 ↗
• MalfunctionJun 14, 2021Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  A PHYSIO-CONTROL 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 ENERGY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11990637 ↗
• MalfunctionSep 17, 2020Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE POWERED OFF BY ITSELF. THERE WAS NO PATIENT USE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10550590 ↗
• MalfunctionOct 31, 2019Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE POWERED OFF BY ITSELF DURING THE MORNING CHECK OF THEIR DEVICE. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9263172 ↗
• MalfunctionSep 3, 2019Failure to Charge; Failure to Charge

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT A NON-CRITICAL ISSUE WITH THEIR DEVICE. UPON EVALUATION PHYSIO FOUND A DEVICE CODE LOGGED IN THE DEVICE'S MEMORY THAT IS INDICATIVE OF A FAILURE OF THE DEVICE TO CHARGE FOR DEFIBRILLATION. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8956645 ↗