LIFEPAK® 15 monitor/defibrillator 99577 (REF 99577-001249)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00883873911709), received between Feb 22, 2019 and Jan 2, 2024 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 2, 2024Failure to Power Up; Failure to Power Up

  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 THAT THE DEVICE DOESN'T POWER ON AS EXPECTED. AS A RESULT, DEFIBRILLATION THERAPY MAY BE DELAYED OR UNAVAILABLE, IF NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18432001 ↗
• MalfunctionJun 14, 2023Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE'S SERVICE INDICATOR IS PRESENT, AND AN EVENT CODE IS LOGGED IN THE DEVICE'S MEMORY. THE EVENT CODE LOGGED IN THE DEVICE'S MEMORY CAN INDICATE THAT THE AED FUNCTION OF THE DEVICE MAY BE INOPERABLE. AS A RESULT, THE UNIT MAY NOT BE ABLE TO ANALYZE A PATIENT'S RHYTHM AND PROVIDE DEFIBRILLATION THERAPY WHILE IN AED MODE IF IT WAS NECESSARY. THERE WAS NO PATIENT INVOLVEMENT REPORTED DURING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17123730 ↗
• MalfunctionJun 1, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE HAD DISPLAYED A BLANK SCREEN AFTER SHOCK DURING TESTING. AS A RESULT, DEFIBRILLATION THERAPY MAY 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 17037443 ↗
• MalfunctionMay 15, 2021Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT IF THEIR DEVICE IS PRESSED ANYWHERE NEAR THE CHARGE BUTTON, IT CHARGES TO 200 JOULES. IN THIS STATE INCORRECT DEFIBRILLATION THERAPY MAY BE DELIVERED. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11829652 ↗
• MalfunctionOct 13, 2020Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE SHUTS OFF WHEN ATTEMPTING TO TRANSMIT VITALS VIA THE CABLE. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THERE WAS NO PATIENT USE REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10672173 ↗
• MalfunctionAug 3, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WENT COMPLETELY BLANK ON A EMS CALL WHILE CHANGING ONE OF THE TWO BATTERIES ON THE DEVICE. NO FURTHER INFORMATION WAS ABLE TO BE PROVIDED. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

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

  MAUDE report 10359426 ↗
• MalfunctionMay 21, 2020Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE UNEXPECTEDLY SHUT DOWN. THERE WAS NO PATIENT USE REPORTED WITH THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 10079891 ↗
• MalfunctionAug 16, 2019Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE UNEXPECTEDLY POWERED OFF WHILE THEY WERE USING IT TO MONITOR A PATIENT. THERE WERE NO REPORTS OF ANY ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE REPORTED ISSUE. PHYSIO-CONTROL CONTACTED THE CUSTOMER TO REQUEST ADDITIONAL INFORMATION ON THE PATIENT. NO RESPONSE HAS BEEN RECEIVED FROM THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8903768 ↗
• MalfunctionFeb 22, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE POWERED OFF AND ON BY ITSELF DURING A PATIENT EVENT. THIS ISSUE IS PATIENT RELATED; HOWEVER THE CUSTOMER ADVISED THAT THERE WAS NO ADVERSE PATIENT OUTCOME. PHYSIO-CONTROL HAS MADE MULTIPLE ATTEMPTS TO CONTACT THE CUSTOMER FOR FURTHER INFORMATION ON THE EVENT AND PATIENT, BUT HAS BEEN UNSUCCESSFUL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8363565 ↗