LIFEPAK® 12 defibrillator/monitor 99400 (REF 99400-002505)Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00885074269252), received between Dec 5, 2018 and Oct 18, 2022 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Unexpected Shutdown” (7 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 18, 2022Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE FAILED TO POWER ON PROPERLY AND ONLY DISPLAYED AN ORANGE SCREEN. 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 EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15628754 ↗
• MalfunctionSep 25, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE IS FREEZING. AS A RESULT, DEFIBRILLATION THERAPY MAY BE UNAVAILABLE, IF NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10590338 ↗
• MalfunctionJul 15, 2020Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE TURNS OFF WHEN BP IS BEING USED. THERE WAS NO PATIENT USE REPORTED WITH THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 10276369 ↗
• MalfunctionApr 8, 2020Device Sensing Problem; Device Sensing Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WOULD NOT RECOGNIZE DEFIBRILLATION ELECTRODES. AS A RESULT, DEFIBRILLATION THERAPY MAY BE UNAVAILABLE, IF NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9936381 ↗
• MalfunctionMar 31, 2020Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE INTERMITTENTLY DISPLAYED A BLACK SCREEN. THIS MAY BE INDICATIVE OF A DEVICE LOCK UP CONDITION. AS A RESULT, DEFIBRILLATION THERAPY MAY BE UNAVAILABLE, IF IT IS NEEDED. THERE WAS NO PATIENT USE REPORTED WITH THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9903782 ↗
• MalfunctionOct 15, 2019Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE POWERED OFF BY ITSELF DURING A PATIENT EVENT. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE PATIENT OUTCOME REPORTED. NO FURTHER DETAILS WERE PROVIDED 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 9195119 ↗
• MalfunctionAug 20, 2019No Display/Image; No Display/Image

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE DISPLAY WAS BLANK. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8913626 ↗
• MalfunctionAug 9, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THE SERVICE INDICATOR IS PRESENT AND AN EVENT CODE IS LOGGED IN THE MEMORY OF THEIR DEVICE. THE EVENT CODE LOGGED IN ITS MEMORY IS INDICATIVE OF A DEVICE FAILURE THAT COULD RESULT IN THE LOSS OF THE DEVICE'S AED FUNCTION. AS A RESULT, DEFIBRILLATION THERAPY MAY BE UNAVAILABLE IF IT WAS NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8879320 ↗
• MalfunctionJul 11, 2019Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEY WERE USING THIS DEVICE TO TAKE A PATIENT'S BLOOD PRESSURE READING AND THE DEVICE UNEXPECTEDLY POWERED OFF. THEY SWAPPED THE DEVICE'S BATTERIES AND WERE ABLE TO POWER IT BACK ON, BUT THE DEVICE UNEXPECTEDLY POWERED OFF AGAIN WHILE ATTEMPTING TO TAKE THE BLOOD PRESSURE READING. 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 PATIENT INFORMATION IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8780688 ↗
• MalfunctionJun 26, 2019Electrical /Electronic Property Problem; Inappropriate or Unexpected Reset; Unexpected Shutdown; Electrical /Electronic Property Problem; Inappropriate or Unexpected Reset; Unexpected Shutdown

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT WHEN ATTEMPTING TO TRANSMIT DATA, THEIR DEVICE POWERS ITSELF OFF, FREEZES OR RESTARTS ITSELF. THIS OCCURRED DURING USE WITH A PATIENT. THERE WERE NO REPORTS OF ADVERSE EFFECTS TO THE PATIENT DUE TO THE REPORTED ISSUE. NO FURTHER DETAILS ABOUT THE PATIENT OR THE EVENT WERE PROVIDED. PHYSIO-CONTROL ATTEMPTED 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 8735414 ↗
• MalfunctionMay 30, 2019Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE POWERED OFF BY ITSELF DURING A PATIENT EVENT. THE CUSTOMER ADVISED THAT NO BUTTONS WERE BEING PRESSED WHEN THE DEVICE POWERED OFF, AND THE DEVICE WAS ABLE TO BE POWERED BACK ON WHEN THE POWER BUTTON WAS PRESSED. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE PATIENT OUTCOME REPORTED BY THE CUSTOMER. NO FURTHER DETAILS WERE PROVIDED 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 8656446 ↗
• MalfunctionMay 13, 2019Failure to Power Up; Failure to Power Up

  A THIRD PARTY SERVICE AGENT CONTACTED PHYSIO-CONTROL TO REPORT THAT THE CUSTOMER'S DEVICE WILL NOT POWER ON. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8603766 ↗
• MalfunctionMay 2, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE DISPLAYS "SERVICE" ACROSS THE DISPLAY DURING PATIENT USE. THIS ISSUE IS INDICATIVE OF A DEVICE LOCK-UP CONDITION THAT COULD DELAY OR PREVENT DEFIBRILLATION IF IT WERE NECESSARY. THERE WERE NO REPORTS OF ADVERSE EFFECTS AS A RESULT OF THE REPORTED ISSUE. PHYSIO-CONTROL HAS MADE MULTIPLE ATTEMPTS TO CONTACT THE CUSTOMER IN ORDER TO OBTAIN ADDITIONAL INFORMATION ABOUT BOTH THE PATIENT AND THE EVENT; HOWEVER, NO RESPONSE HAS BEEN RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8574403 ↗
• MalfunctionApr 10, 2019Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE UNEXPECTEDLY POWERED ITSELF OFF. THE CREW HAD TO PRESS THE POWER BUTTON TO TURN THE DEVICE BACK ON. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 8501873 ↗
• MalfunctionApr 1, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT UPON POWER ON, THEIR DEVICE WAS LOCKED UP AND WOULD ALLOW ANY FUNCTIONS TO OPERATE. WHEN THIS OCCURRED THE SERVICE INDICATOR WAS ILLUMINATED. 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 Patient Involvement

  MAUDE report 8471666 ↗
• MalfunctionMar 29, 2019Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEY WERE USING THIS DEVICE ON A PATIENT AND IT SEEMED TO POWER OFF UNEXPECTEDLY. 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 8466951 ↗
• MalfunctionFeb 6, 2019Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THEIR DEVICE POWERED ITSELF OFF AND THEY ALSO STATED THAT IT DRAINS THE BATTERIES IN THE DEVICE. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 8313405 ↗
• MalfunctionJan 25, 2019Energy Output Problem; Energy Output Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT A NON-CRITICAL ISSUE WITH THEIR DEVICE. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT. UPON EVALUATION OF THE CUSTOMER'S DEVICE, PHYSIO-CONTROL OBSERVED THAT THE DEVICE DELIVERED 207 JOULES AT A SELECTED ENERGY LEVEL OF 100 JOULES. AS A RESULT, THE INCORRECT DEFIBRILLATION THERAPY MAY BE DELIVERED TO A PATIENT, IF IT WAS NEEDED.

  Patient problems: No Patient Involvement

  MAUDE report 8278344 ↗
• MalfunctionJan 4, 2019Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT BATTERY WELL #1 IN THE DEVICE WAS NOT WORKING. THE DEVICE WOULD NOT POWER ON WHEN THERE WAS A BATTERY IN BATTERY WELL #1 ONLY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8220281 ↗
• MalfunctionDec 5, 2018Device Sensing Problem; Device Sensing Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THE DEVICE IS UNABLE TO MONITOR PADDLES ECG. AS A RESULT, DEFIBRILLATION THERAPY MAY NOT BE AVAILABLE TO A PATIENT IF NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 8135920 ↗