LIFEPAK® 15 monitor/defibrillator 99577 (REF 99577-001932)Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00883873872079), received between Jul 30, 2018 and May 10, 2024 — classified as 1 injury, 27 malfunctions.

The most frequently reported specific device problem is “Unexpected Shutdown” (6 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 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 10, 2024Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE HAD UNEXPECTEDLY LOST POWER. AS A RESULT, DEFIBRILLATION 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 19285037 ↗
• MalfunctionDec 5, 2023Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE DID NOT DELIVER A DEFIBRILLATION SHOCK DURING A PATIENT EVENT. IN THIS STATE, DEFIBRILLATION THERAPY MAY BE DELAYED OR PREVENTED FROM BEING DELIVERED TO THE PATIENT IF NEEDED. THIS ISSUE IS PATIENT RELATED; HOWEVER, THERE WAS NO ADVERSE PATIENT OUTCOME REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18271339 ↗
• MalfunctionSep 7, 2023Defibrillation/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 17699663 ↗
• MalfunctionJul 7, 2023Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR INTERNAL PADDLES CONNECTED TO THE DEVICE WOULD NOT PROVIDE SHOCK WHEN ATTEMPTED. 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 17278758 ↗
• MalfunctionMar 17, 2022Failure to Deliver Energy; Failure to Deliver Energy

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WAS NOT DELIVERING DEFIBRILLATION ENERGY. CUSTOMER FURTHER ADVISED THE DEVICE'S SHOCK BUTTON WAS NOT FUNCTIONING. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13796041 ↗
• MalfunctionJan 12, 2022Failure to Deliver Energy; Failure to Deliver Energy

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THERE WAS AN EVENT CODE LOGGED IN THE DEVICE'S MEMORY. THE EVENT CODE LOGGED IS RELATED TO A POTENTIAL FAILURE OF THE DEVICE TO DELIVER DEFIBRILLATION ENERGY. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13239710 ↗
• MalfunctionDec 6, 2021Failure to Charge; Failure to Charge

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE HAD AN EVENT CODE LOGGED IN ITS MEMORY. THE EVENT CODE LOGGED IN THE DEVICE'S MEMORY IS INDICATIVE OF A FAILURE OF THE DEVICE TO CHARGE DEFIBRILLATION ENERGY. AS A RESULT, DEFIBRILLATION THERAPY MAY NOT BE AVAILABLE, IF NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12935321 ↗
• MalfunctionJul 13, 2021Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE LOGGED A CRITICAL EVENT CODE. THE EVENT CODE IS RELATED TO A POTENTIAL ISSUE OF THE DEVICE TO DELIVER ENERGY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12163682 ↗
• MalfunctionJul 7, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE'S SCREEN FROZE FOR 10 SECONDS WHILE IN USE. THIS ISSUE IS PATIENT RELATED, THE USER REPORTED THEY COULD NOT DETERMINE THE PATIENT'S ECG RHYTHM OR PROVIDE DEFIBRILLATION IF NEEDED; HOWEVER NO SERIOUS INJURY OR DEATH HAS BEEN REPORTED AT THIS TIME.

  Patient problems: Ventricular Fibrillation

  MAUDE report 12131397 ↗
• MalfunctionJul 6, 2021Failure to Charge; Failure to Charge

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THERE WAS AN EVENT CODE LOGGED IN THEIR DEVICE'S MEMORY. THE EVENT CODE LOGGED IN THE DEVICE'S MEMORY 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 12123199 ↗
• MalfunctionJul 1, 2021Failure to Charge; Defibrillation/Stimulation Problem; Failure to Charge; Defibrillation/Stimulation Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE LOGGED A CRITICAL EVENT CODE. THE EVENT CODE IS RELATED TO A POTENTIAL ISSUE OF THE DEVICE TO DELIVER ENERGY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12099944 ↗
• MalfunctionJun 15, 2021Failure to Charge; Unexpected Shutdown; Failure to Charge; Unexpected Shutdown

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE UNEXPECTEDLY POWERED OFF DURING A PATIENT EVENT. UPON POWERING THE DEVICE BACK ON, THE CUSTOMER OBSERVED THAT THE DEVICE'S SERVICE INDICATOR WAS ILLUMINATED AND AN EVENT CODE WAS LOGGED IN THE DEVICE'S MEMORY. THE EVENT CODE LOGGED IS INDICATIVE OF A FAILURE OF THE DEVICE TO CHARGE DEFIBRILLATION ENERGY. AS A RESULT, DEFIBRILLATION THERAPY MAY HAVE BEEN UNAVAILABLE, IF NEEDED. 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 12005257 ↗
• MalfunctionJun 15, 2021Failure to Charge; Unexpected Shutdown; Failure to Charge; Unexpected Shutdown

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE UNEXPECTEDLY POWERED OFF DURING A PATIENT EVENT. UPON POWERING THE DEVICE BACK ON, THE CUSTOMER OBSERVED THAT THE DEVICE'S SERVICE INDICATOR WAS ILLUMINATED AND AN EVENT CODE WAS LOGGED IN THE DEVICE'S MEMORY. THE EVENT CODE LOGGED IS INDICATIVE OF A FAILURE OF THE DEVICE TO CHARGE DEFIBRILLATION ENERGY. AS A RESULT, DEFIBRILLATION THERAPY MAY HAVE BEEN UNAVAILABLE, IF NEEDED. 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 12005254 ↗
• MalfunctionJun 11, 2021Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WOULD NOT POWER ON. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11985555 ↗
• MalfunctionApr 7, 2021Power Problem; Power Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THE POWER BUTTON ON THEIR DEVICE WAS NOT WORKING AND WOULD NOT POWER THE DEVICE ON OR OFF. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11627631 ↗
• MalfunctionOct 27, 2020Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WOULD NOT POWER ON. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10744667 ↗
• MalfunctionSep 29, 2020Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  THE CUSTOMER STATED THE DEVICE DUMPED THE CHARGE BEFORE THE CUSTOMER WAS READY TO DELIVER SHOCK. THE CUSTOMER WAS CONTACTED TO CONFIRM THERE WAS NO PATIENT USE REPORTED WITH THE EVENT. THE CUSTOMER HAS NOT RESPONDED WITH ADDITIONAL INFORMATION AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10603777 ↗
• InjurySep 16, 2020Use of Device Problem; Use of Device Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT WHEN USING THEIR DEVICE THAT UNIT SHOCKED PATIENT INTO V-FIB, UNIT ISN'T SYNCING PROPERLY. THE PATIENT RECEIVED A SYNCHRONIZED CARDIOVERSION DURING THE VULNERABLE PERIOD OF THEIR ECG WHICH CAUSED THEM TO CONVERT TO VENTRICULAR FIBRILLATION. DEFIBRILLATION WAS REQUIRED TO ACHIEVE A RETURN OF SPONTANEOUS CIRCULATION, THE PATIENT SURVIVED THE EVENT.

  Patient problems: Ventricular Fibrillation

  MAUDE report 10541193 ↗
• MalfunctionSep 8, 2020Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WAS UNABLE TO DELIVER DEFIBRILLATION THERAPY DURING A PATIENT EVENT. THE CUSTOMER ADVISED THAT WITH THE USE OF THE PATIENT'S INTERNAL PACE MAKER THEY WERE ABLE TO GET THE HEART BACK TO A CORRECT ARRHYTHMIA. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE PATIENT OUTCOME REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10500598 ↗
• MalfunctionFeb 18, 2020Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WOULD DISARM ITSELF 8 SECONDS AFTER BEING CHARGED FOR DEFIBRILLATION. IN THIS STATE DEFIBRILLATION THERAPY MAY BE DELAYED OR UNAVAILABLE IF NEEDED. THE PATIENT DID SURVIVE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9722829 ↗
• MalfunctionSep 23, 2019Failure to Deliver Energy; Failure to Deliver Energy

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE DISPLAY WENT BLANK AND SHOCK WAS NOT DELIVERED. A BLANK DISPLAY CAN BE INDICATIVE OF A DEVICE LOCK UP CONDITION AND AS A RESULT, DEFIBRILLATION THERAPY MAY BE UNAVAILABLE, IF IT IS NEEDED. THE CUSTOMER WAS UNABLE TO PROVIDE ANY FURTHER INFORMATION FOR THE EVENT OR THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9107641 ↗
• MalfunctionAug 7, 2019Aborted Charge; Aborted Charge

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEY WERE USING THIS DEVICE ON A PATIENT AND THE DEVICE UNEXPECTEDLY DUMPED ITS DEFIBRILLATION ENERGY CHARGE. A RESULT, DEFIBRILLATION THERAPY MAY HAVE BEEN DELAYED OR 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 8872499 ↗
• MalfunctionJun 26, 2019Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEY WERE USING THIS DEVICE ON A PATIENT WHILE THEY WERE IMPLANTING AN AUTOMATIC IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (AICD). THE USERS PUT THE PATIENT INTO V-FIB AND THEN THE AICD FAILED. THEY TRIED TO USE THE AICD AND IT FAILED AGAIN. THEY THEN CHARGED THE DEVICE AND TRIED TO SHOCK THE PATIENT AND IT DID NOT DELIVER A SHOCK AND THE PATIENT'S ECG WENT TO A DASHED LINE. THEY CHARGED THE AICD AND THE DEVICE AGAIN AND WERE ABLE TO DELIVER A SHOCK TO THE PATIENT WITH BOTH DEVICES AT ABOUT THE SAME TIME. THE PATIENT'S RHYTHM WAS SUCCESSFULLY CONVERTED. THERE WERE NO REPORTS OF ANY ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE REPORTED ISSUE. THE CUSTOMER INFORMED PHYSIO-CONTROL THAT NO ADDITIONAL PATIENT INFORMATION IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8735491 ↗
• MalfunctionJun 5, 2019Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT WHILE USING THEIR DEVICE TO MONITOR A PATIENT IN THE CATHETERIZATION LAB, THE DEVICE INTERMITTENTLY POWERED ITSELF OFF. THERE WERE 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 8672350 ↗
• MalfunctionMar 18, 2019Failure to Deliver Energy; Failure to Deliver Energy

  THE CUSTOMER, A BIOMEDICAL ENGINEER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WAS UNABLE TO DELIVER DEFIBRILLATION THERAPY DURING A PATIENT EVENT. THE CUSTOMER ADVISED THAT ON THE FOURTH ATTEMPT TO SHOCK THE PATIENT, THE ENERGY WAS DELIVERED. THE PATIENT WAS A FEMALE. THE CUSTOMER ADVISED THAT THERE WERE NO ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE REPORTED ISSUE. PHYSIO-CONTROL CONTACTED THE CUSTOMER IN ORDER TO OBTAIN ADDITIONAL INFORMATION ABOUT BOTH THE PATIENT AND THE EVENT, HOWEVER, THE CUSTOMER WAS UNABLE PROVIDE FURTHER INFORMATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8429288 ↗