LIFEPAK® 15 monitor/defibrillator 99577 (REF 99577-001247)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00883873911723), received between Jun 4, 2018 and Aug 27, 2026 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Unexpected Shutdown” (9 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2026Electrical /Electronic Property Problem

  The customer contacted Stryker to report that their device would not complete a boot cycle. The customer advised that the device powers on then off. In this state the device would be inoperable and 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 50477362 ↗
• MalfunctionMar 5, 2025Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  THE CUSTOMER CONTACTED STRYKER TO REPORT A NON-CRITICAL ISSUE WITH THEIR DEVICE. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT. UPON EVALUATION, STRYKER OBSERVED THAT THE MAIN KEYPAD OF THE CUSTOMER'S DEVICE WAS UNRESPONSIVE. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY, IF NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21529852 ↗
• MalfunctionFeb 26, 2025Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE SHUT OFF DURING USE. IN THIS STATE THE DEVICE WOULD BE INOPERABLE AND DEFIBRILLATION THERAPY WOULD NOT BE AVAILABLE IF NEEDED. THIS ISSUE IS PATIENT RELATED; HOWEVER, THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21468946 ↗
• MalfunctionDec 16, 2020Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE UNEXPECTEDLY LOST POWER WHILE IN USE WITH A PATIENT THREE TIMES. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11016996 ↗
• MalfunctionOct 29, 2020Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE EXHIBITED THE SERVICE WRENCH LED AND SHUT DOWN UNEXPECTEDLY. THE CUSTOMER FOUND AN EVENT CODE LOGGED IN ITS MEMORY IS INDICATIVE OF A DEVICE FAILURE THAT COULD RESULT IN THE DISPLAY MIGHT HAVE GONE BLANK. IN THIS STATE THE DEVICE MAY DELAY OR NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: Cardiac Arrest

  MAUDE report 10756162 ↗
• MalfunctionSep 24, 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 REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10583727 ↗
• MalfunctionMar 3, 2020Failure to Analyze Signal; Failure to Analyze Signal

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE FAILS THE USER TEST. UPON EVALUATION PHYSIO CONFIRMED THE ISSUE NOTING THE SERVICE INDICATOR WAS ILLUMINATE AND AN EVENT CODE WAS LOGGED IN THE DEVICES 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 USE REPORTED WITH THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9781073 ↗
• MalfunctionJan 2, 2020Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE UNEXPECTEDLY SHUT OFF MULTIPLE TIMES. 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 PATIENT OUTCOME REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9538538 ↗
• MalfunctionApr 11, 2019Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE POWERED OFF MULTIPLE TIMES BY ITSELF WHEN THE CODE SUMMARY BUTTON ON THE DEVICE WAS PRESSED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8507099 ↗
• MalfunctionMar 26, 2019Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT AFTER PRESSING THE CODE SUMMARY BUTTON, THEIR DEVICE APPEARED TO RESET ITSELF. 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. PHYSIO-CONTROL HAS MADE MULTIPLE ATTEMPTS TO CONTACT THE CUSTOMER IN ORDER TO OBTAIN ADDITIONAL INFORMATION ON THE PATIENT; HOWEVER, NO RESPONSE HAS BEEN RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8454355 ↗
• MalfunctionMar 22, 2019Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE POWERED OFF UNEXPECTEDLY WHEN THE CODE SUMMARY BUTTON WAS PRESSED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8446477 ↗
• MalfunctionMar 6, 2019Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE INTERMITTENTLY SHUTS DOWN DURING USE. IT WAS LAST OBSERVED DURING A SHIFT CHECK. THERE WERE NO REPORTS OF SPECIFIC PATIENT USE ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 8394643 ↗
• MalfunctionMar 5, 2019Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT WHEN ATTEMPTING TO PRINT THE CODE SUMMARY, THEIR DEVICE POWERED ITSELF OFF. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 8392872 ↗
• MalfunctionDec 27, 2018Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT WHILE THEIR DEVICE WAS MONITORING A PATIENT, THE DEVICE POWERED ITSELF OFF. THE AMBULANCE WAS IN MOTION AT THE TIME THE SHUT DOWN OCCURRED. THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8201593 ↗
• MalfunctionOct 9, 2018Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE DISPLAYED A SERVICE WRENCH. UPON EVALUATION OF THE CUSTOMER¿S DEVICE, PHYSIO-CONTROL OBSERVED THAT THE DEVICE DISPLAYED AN "ABNORMAL ENERGY DELIVERED" MESSAGE. AS A RESULT, THE WRONG DEFIBRILLATION OR NO DEFIBRILLATION THERAPY WOULD BE DELIVERED, IF IT WERE NECESSARY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7949617 ↗
• MalfunctionSep 6, 2018Failure to Analyze Signal; Failure to Analyze Signal

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE HAD A SERVICE INDICATOR PRESENT AND AN EVENT CODE IN THE MEMORY WHICH INDICATES THAT THE AED FUNCTION OF THE DEVICE MAY BE INOPERABLE AND, 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 WERE NECESSARY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7853760 ↗
• MalfunctionJun 4, 2018Failure To Run On AC/DC; Failure To Run On AC/DC

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT WHEN ATTEMPTING TO POWER ON THEIR DEVICE, IT WILL NOT POWER ON. THE DEVICE WILL NOT POWER ON WHEN PLUGGED INTO AC AND THE DEVICE HAS TWO FULLY CHARGED BATTERIES INSTALLED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7566506 ↗