LIFEPAK® 15 monitor/defibrillator 99577 (REF 99577-001962)Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00883873871645), received between Jun 19, 2018 and Feb 20, 2024 — classified as 1 death, 25 malfunctions.

The most frequently reported specific device problem is “Unexpected Shutdown” (10 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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2024Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE POWER CYCLED MULTIPLE TIME DURING PATIENT USE. 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

  MAUDE report 18736964 ↗
• MalfunctionFeb 1, 2024Charging Problem; Charging Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD CHARGE SLOWLY. THIS ISSUE HAS THE POTENTIAL TO DELAY THE DELIVERY OF DEFIBRILLATION. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18623708 ↗
• MalfunctionJan 5, 2024Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE UNEXPECTEDLY POWERED OFF. IN THIS STATE THE DEVICE WOULD BE INOPERABLE AND DEFIBRILLATION THERAPY WOULD NOT BE AVAILABLE IF NEEDED. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18460802 ↗
• MalfunctionSep 18, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WAS NOT COMPLETING THE BOOTING-UP CYCLE DURING THE INITIAL POWER ON. AS A RESULT, DEFIBRILLATION THERAPY 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 17769931 ↗
• MalfunctionSep 7, 2023Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE UNEXPECTEDLY LOST POWER DURING AMBULANCE RIDE WITH A PATIENT. 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 17699785 ↗
• MalfunctionAug 14, 2023Failure to Power Up; Failure to Power Up

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NOT POWER ON. AS A RESULT, DEFIBRILLATION THERAPY 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 17541656 ↗
• MalfunctionAug 8, 2023Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE UNEXPECTEDLY LOST POWER. IN THIS STATE THE DEVICE WOULD 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 17481823 ↗
• MalfunctionJun 28, 2023Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE UNEXPECTEDLY POWERED OFF. IN THIS STATE, THE DEVICE MAY BE UNABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THIS ISSUE IS PATIENT RELATED; HOWEVER, NO ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17215221 ↗
• MalfunctionMar 15, 2023Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE FAILED THE 3AM TEST AND LOGGED AN EVENT CODE IN THE DEVICE¿S MEMORY. THE CODE IS INDICATIVE OF A DEVICE FAILURE THAT COULD RESULT IN A PARTIAL LOSS OF DEFIBRILLATOR OUTPUT ENERGY DUE TO A LOSS OF THE NEGATIVE PORTION OF THE BIPHASIC OUTPUT WAVEFORM, RESULTING IN A MONOPHASIC SHOCK. ADDITIONALLY, THE DEFIBRILLATOR OUTPUT ENERGY MAY BE REDUCED BY UP TO APPROXIMATELY 20% FROM THE SELECTED ENERGY LEVEL. AS A RESULT, THE WRONG DEFIBRILLATION THERAPY WOULD BE DELIVERED, IF IT WERE NECESSARY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16547595 ↗
• MalfunctionNov 15, 2022Connection Problem; Connection Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT A NON-CRITICAL ISSUE WITH THEIR DEVICE. DURING EVALUATION IT WAS FOUND THAT THEIR DEFIBRILLATION CONNECTION HAD DEBRIS BUILD UP THAT WAS CAUSING A CONNECTION PROBLEM WITH THE THERAPY CABLE. 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 15801573 ↗
• MalfunctionJul 15, 2022Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  DURING ROUTINE PREVENTATIVE MAINTENANCE TESTING BY STRYKER, THE DEVICE LOGGED AN EVENT CODE WHICH IS INDICATIVE OF A DEVICE FAILURE THAT COULD RESULT IN A PARTIAL LOSS OF DEFIBRILLATOR OUTPUT ENERGY DUE TO A LOSS OF THE NEGATIVE PORTION OF THE BIPHASIC OUTPUT WAVEFORM, RESULTING IN A MONOPHASIC SHOCK. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15025150 ↗
• MalfunctionJan 24, 2022Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WILL NOT POWER ON. WHEN THEY ATTEMPT TO TURN IT ON, THE DEVICE'S DISPLAY FLASHES WHITE AND THEN IT POWERS OFF. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13334363 ↗
• MalfunctionDec 28, 2021Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE UNEXPECTEDLY DISPLAYED A WHITE SCREEN AND POWERED OFF. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13096412 ↗
• MalfunctionDec 9, 2021Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THE ANALYZE BUTTON ON THEIR DEVICE FUNCTIONED INTERMITTENTLY. IN THIS STATE, THE DEVICE MAY NOT HAVE THE ABILITY TO FUNCTION IN AED MODE, AND THE NEED FOR DEFIBRILLATION THERAPY MAY NOT BE DETERMINED. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE PATIENT OUTCOME REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12970558 ↗
• MalfunctionOct 6, 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 10639383 ↗
• MalfunctionApr 8, 2020Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE POWERED OFF AND CREW POWERED IT BACK ON OR THE DEVICE REBOOTED ON IT'S OWN. AN UNEXPECTED SHUTDOWN COULD DELAY DEFIBRILLATION THERAPY IF NEEDED. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE PATIENT OUTCOME REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9941215 ↗
• MalfunctionJan 21, 2020Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WOULD RANDOMLY RESET ITSELF, POWERING OFF AND ON. AFTER SEVERAL CYCLES OF THIS, THE DEVICE WOULD REMAIN AND FUNCTION NORMALLY. IN THIS STATE DEFIBRILLATION THERAPY MAY BE DELAYED OR UNAVAILABLE IF NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9614091 ↗
• MalfunctionJun 25, 2019Failure to Charge; Failure to Charge

  PHYSIO-CONTROL WAS PERFORMING PREVENTATIVE MAINTENANCE ON A CUSTOMER'S DEVICE AND OBSERVED AN EVENT CODE LOGGED IN THE DEVICE'S MEMORY. THE EVENT CODE LOGGED IS ASSOCIATED WITH A FAILURE OF THE DEVICE TO CHARGE FOR DEFIBRILLATION ENERGY.  AT THE TIME WHEN THE CODE IS LOGGED BY THE DEVICE, ITS CHARGE FUNCTION WOULD BE DISABLED. AS A RESULT, DEFIBRILLATION WOULD NOT BE POSSIBLE, IF IT WERE NECESSARY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8732997 ↗
• MalfunctionJun 5, 2019Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT WHILE MONITORING (B)(6) YEAR OLD MALE PATIENT IN THE ELECTRO SURGICAL UNIT, THEIR DEVICE POWERED ITSELF OFF. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE REPORTED ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8672358 ↗
• MalfunctionApr 26, 2019Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE UNEXPECTEDLY POWERED ITSELF OFF AND BACK ON WHILE THEY WERE USING IT ON A PATIENT. THERE WERE NO REPORTS OF ANY ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE REPORTED ISSUE. THE CUSTOMER ADVISED PHYSIO-CONTROL THAT NO ADDITIONAL PATIENT INFORMATION IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8558625 ↗
• MalfunctionApr 25, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER, A BIOMEDICAL ENGINEER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE CYCLED POWER BY ITSELF TWICE DURING A PATIENT EVENT. THE CUSTOMER ADVISED THAT THE DEVICE CYCLED POWER THE FIRST TIME AFTER A BLOOD PRESSURE READING WAS TAKEN WHILE THE APNEA ALARM WAS SOUNDING. SHORTLY THEREAFTER, THE DEVICE CYCLED POWER AGAIN. AFTER THE SECOND POWER CYCLE, THE DEVICE FUNCTIONED PROPERLY FOR THE REST OF THE CASE. THE DEVICE WAS REPORTED TO BE STATIONARY AND CONNECTED TO AC POWER. THE PATIENT WAS BEING MONITORED ONLY. THE CUSTOMER ADVISED THAT THERE WERE NO ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE REPORTED ISSUE. THE CUSTOMER WAS UNABLE TO PROVIDE FURTHER DETAILS ON THE EVENT OR THE PATIENT. . EACH TIME THE DEVICE WAS POWERED BACK ON BY THE CUSTOMER. AFTER THE LAST POWER OFF, THE CUSTOMER REMOVED AND RESEATED THE BATTERIES. THEREAFTER, PROPER DEVICE OPERATION WAS OBSERVED FOR THE REST OF THE PATIENT TRANSPORT. THE DEVICE WAS USED FOR PATIENT MONITORING ONLY. THE PATIENT, A 75 YEAR OLD FEMALE DID SURVIVE. THE CUSTOMER ADVISED THAT THERE WERE NO ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE REPORTED ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8553237 ↗
• DeathFeb 11, 2019Failure to Deliver Energy; Incorrect Interpretation of Signal; Failure to Deliver Energy; Incorrect Interpretation of Signal

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THE FOLLOWING: "DURING THE CARDIAC ARREST TODAY, I HAD A PROBLEM WITH THE 3A LP15. DURING A RHYTHM CHECK, THE PATIENT WAS NOTED TO BE IN VFIB. THE MONITOR WAS CHARGED AND THE PATIENT DEFIBRILLATED. FOLLOWING A NORMAL/UNEVENTFUL DEFIBRILLATION, THERE WAS A DISTINCT BURNING SMELL. HOWEVER, THE SMELL WAS MUCH MORE OF AN ELECTRICAL NATURE THAT A HUMAN FLESH/HAIR SMELL. AT THE SAME TIME, I SUDDENLY LOST READINGS WHILE VIEWING THE RHYTHM THROUGH THE "PADDLES" MODE. IT WAS JUST A PERFECTLY STRAIGHT LINE, TOO PERFECT FOR EVEN ASYSTOLE. IN FACT, IT LOOKED LIKE THE MONITOR WAS HOOKED TO A RHYTHM GENERATOR THAT WAS TURNED OFF. THIS WAS ALL WHILE COMPRESSIONS WERE ACTIVELY BEING PERFORMED. I CHECKED THE CONNECTION AND PAD CONTACT, WHICH WERE BOTH FINE. I SWAPPED TO LEAD II, AND NOTED A NORMAL CPR ARTIFACT RHYTHM. SUSPECTING FAULTY PADS, I SWAPPED PADS BUT HAD SIMILAR DIFFICULTIES VIEWING AND ACCURATE RHYTHM THROUGH "PADDLES" MODE. I THEN DEFIBRILLATED THE PATIENT AGAIN, VIEWING VFIB THROUGH THE LIMB LEADS AND USING THE PADS TO ONLY DEFIBRILLATE, WHICH APPEARED TO HAPPEN WITHOUT A PROBLEM." THE REPORTED INABILITY TO VIEW THE PATIENT'S ECG WAVEFORM

  Patient problems: Death; No Known Impact Or Consequence To Patient

  MAUDE report 8325943 ↗
• MalfunctionSep 14, 2018Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WOULD NO LONGER POWER ON WHEN PROMPTED. THE CUSTOMER ADVISED PHYSIO THAT THE CREW HAD A THIRD PARTY USB DATA CABLE CONNECTED TO THE DEVICE'S SYSTEM CONNECTOR WHEN THE REPORTED ISSUE WAS OBSERVED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7879327 ↗
• MalfunctionAug 20, 2018Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT INTERMITTENTLY THEIR DEVICE WOULD HAVE A BLANK DISPLAY. WHEN THIS OCCURRED THE DEVICE BUTTONS WERE UNRESPONSIVE. IN THIS STATE DEFIBRILLATION THERAPY MAY NOT BE AVAILABLE TO A PATIENT IF NEEDED. THERE WAS NO PATIENT USE REPORTED FOR THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7799519 ↗
• MalfunctionJul 9, 2018Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE POWERED OFF BY ITSELF DURING A PATIENT EVENT. THIS ISSUE OCCURRED WHEN TAKING A BLOOD PRESSURE MEASUREMENT AND A 12 LEAD ECG READING. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE PATIENT OUTCOME REPORTED BY THE CUSTOMER. PHYSIO-CONTROL MADE MULTIPLE ATTEMPTS TO CONTACT THE CUSTOMER IN ORDER TO OBTAIN ADDITIONAL INFORMATION ABOUT BOTH THE PATIENT AND THE EVENT, BUT HAS BEEN UNSUCCESSFUL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7672155 ↗