LIFEPAK® 15 monitor/defibrillator 99577 (REF 99577-001238)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00883873911815), received between Jul 17, 2018 and Nov 25, 2025 — classified as 12 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 25, 2025Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE IS NOT SHOCKING WHEN PRESSING THE SHOCK BUTTON. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO PROVIDE DEFIBRILLATION THERAPY, IF IT WERE NEEDED. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE PATIENT OUTCOME REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23644439 ↗
• MalfunctionFeb 27, 2025Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED STRYKER TO REPORT A NON-CRITICAL ISSUE WITH THEIR DEVICE. UPON EVALUATION OF THE CUSTOMER'S DEVICE, STRYKER OBSERVED THAT 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 USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21480034 ↗
• MalfunctionMay 14, 2024Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THE BUTTONS ON THE DEVICE ARE NOT WORKING. 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 19316291 ↗
• MalfunctionApr 11, 2023Device Sensing Problem; Device Sensing Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE DID NOT RECOGNIZE THE THERAPY CABLE. IN THIS STATE, THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THERE WAS NO PATIENT INVOLVEMENT REPORTED DURING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16710798 ↗
• MalfunctionMay 24, 2022Charging Problem; Charging Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEY WERE USING THIS DEVICE DURING A PATIENT EVENT AND WHEN THEY WENT TO CHARGE THE DEVICE TO DELIVER DEFIBRILLATION ENERGY, THE DEVICE TOOK TOO LONG TO CHARGE. THE USER(S) SWITCHED TO A BACK UP DEVICE AND USED THAT TO CONTINUE PATIENT CARE. 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

  MAUDE report 14489465 ↗
• MalfunctionMar 29, 2021Failure to Deliver Energy; Failure to Deliver Energy

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WAS USED DURING A CATH LAB PROCEDURE, HAD ECG, AND ELECTRODES ATTACHED TO THE PATIENT. WHEN TRYING TO SHOCK THE PATIENT THE CUSTOMER STATED "ADVISORY" MODE POPULATED ON THE DEVICE AND WOULD NOT GO AWAY. CUSTOMER THEN HAD TO RETRIEVE ANOTHER DEVICE TO PERFORM THERAPY DELIVERY. THIS ISSUE IS PATIENT RELATED; HOWEVER THE CUSTOMER CONFIRMED THE DEVICE USE DID NOT CONTRIBUTE TO A SERIOUS INJURY OR DEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11580867 ↗
• MalfunctionFeb 22, 2021Failure to Charge; Failure to Charge

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE DID NOT RESPOND TO CHARGE BUTTON INPUT FROM THE USER. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO CHARGE AND DELIVER DEFIBRILLATION THERAPY IF NEEDED. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: Arrhythmia

  MAUDE report 11358684 ↗
• MalfunctionMar 29, 2019Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEY ATTEMPTED TO POWER THE DEVICE ON BY PRESSING THE ON/OFF BUTTON. THE DEVICE STARTED TO TURN ON, BUT AS SOON AS THE ON/OFF BUTTON WAS RELEASED, THE DEVICE UNEXPECTEDLY POWERED OFF. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8466325 ↗
• MalfunctionMar 7, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE CHARGED AND DELIVERED DEFIBRILLATION ENERGY SUCCESSFULLY. AFTER THE DELIVERY OF ENERGY THE SCREEN REMAINED BLACKED OUT AND THEIR DEVICE APPEARED TO BE LOCKED UP, WHEN THIS OCCURRED THE LEDS ON THE DEVICE WERE ILLUMINATED, HOWEVER THE KEYPAD BUTTONS WERE UNRESPONSIVE. THE CUSTOMER ADVISED THAT THE DEVICE WAS SHOCKED 10 TIMES, IT WAS AFTER THE 10TH SHOCK THAT THE DEVICE LOCK UP OCCURRED. THIS EVENT TOOK PLACE DURING SCHEDULED TESTING OF THE CUSTOMER'S DEVICE. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE.

  Patient problems: No Patient Involvement

  MAUDE report 8402310 ↗
• MalfunctionFeb 26, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEY WERE USING THIS DEVICE ON A PATIENT AND WHEN THEY SHOCKED THE PATIENT THE DEVICE'S DISPLAY WENT COMPLETELY BLACK AND THE DEVICE'S WAS NOT RESPONDING. THERE WAS A BACK UP DEVICE AVAILABLE BUT IT IS UNKNOWN WHETHER OR NOT THAT DEVICE WAS USED. AS A RESULT, DEFIBRILLATION THERAPY MAY HAVE BEEN UNAVAILABLE, IF IT WAS NEEDED. 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 8372601 ↗
• MalfunctionOct 30, 2018Electrical /Electronic Property Problem; Failure to Deliver Energy; Electrical /Electronic Property Problem; Failure to Deliver Energy

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WAS UNABLE TO DELIVER DEFIBRILLATION ENERGY. THE CUSTOMER ADVISED, THAT WHEN THE SHOCK BUTTON WAS PRESSED TO DELIVER THE ENERGY, THE DEVICE WOULD DISARM AND DUMP THE ENERGY CHARGE INTERNALLY. THE CUSTOMER INDICATED THAT THIS HAPPENED CONSISTENTLY AT THE 100, 300 AND 360 JOULE SETTINGS, AND INTERMITTENTLY AT 200 JOULES. WHEN THIS OCCURRED THEIR DEVICE SERVICE INDICATOR WAS ILLUMINATED AND THEIR DEVICE LOGGED AN EVENT CODE IN THE DEVICE¿S MEMORY THAT IS RELATED TO A POTENTIAL FAILURE OF THE DEVICE TO DELIVER DEFIBRILLATION ENERGY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8020394 ↗
• MalfunctionJul 17, 2018Connection Problem; Connection Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT DURING A PATIENT EVENT, THE DEVICE WOULD NOT DETECT THAT ELECTRODES WERE CONNECTED. THE DEVICE GAVE A "CONNECT ELECTRODES" MESSAGE EVEN THOUGH THE PATIENT WAS CONNECTED TO THE DEVICE. THE PATIENT SURVIVED THE EVENT AND THERE WAS NO ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE REPORTED ISSUE. NO FURTHER DETAILS ABOUT THE PATIENT OR THE EVENT WERE PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7696191 ↗