LIFEPAK® 12 defibrillator/monitor 99400 (REF 99400-003505)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00885074857749), received between Dec 19, 2018 and Mar 16, 2021 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Unexpected Shutdown” (8 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.

• MalfunctionMar 16, 2021Unexpected Shutdown; Unexpected Shutdown

  UPON EVALUATION OF THE CUSTOMER'S DEVICE, PHYSIO-CONTROL OBSERVED THAT THE DEVICE WOULD POWER ITSELF DOWN A FEW SECONDS AFTER BEING TURNED ON. . PATIENT INVOLVEMENT WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11499677 ↗
• MalfunctionAug 22, 2019Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE UNEXPECTEDLY POWERED OFF 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 INFORMED PHYSIO-CONTROL THAT NO ADDITIONAL PATIENT INFORMATION IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8923779 ↗
• MalfunctionJul 15, 2019Electrical /Electronic Property Problem; Unexpected Shutdown; Electrical /Electronic Property Problem; Unexpected Shutdown

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WOULD FREEZE OR POWER ITSELF OFF WHEN TRANSMITTING DATA. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8791781 ↗
• MalfunctionJun 19, 2019Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE IS UNEXPECTEDLY POWERING ITSELF OFF AND ON. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8712655 ↗
• MalfunctionMay 7, 2019Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT WHILE A (B)(6) FEMALE WAS IN CARDIAC ARREST, THEIR DEVICE POWERED ITSELF OFF WHILE PERFORMING CPR ON THE PATIENT AND THEN POWERED ITSELF OFF WHILE WAITING FOR THE 12 LEAD TO PRINT. THE PATIENT HAD A PULSE ON ARRIVAL AT THE HOSPITAL BUT IS NOW DECEASED. THE CUSTOMER REPORTED THAT THE DEVICE ISSUE DID NOT CAUSE OR CONTRIBUTE AS THE PATIENT DID NOT NEED TO BE DEFIBRILLATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8588842 ↗
• MalfunctionApr 10, 2019Failure to Power Up; Failure to Power Up

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

  Patient problems: No Patient Involvement

  MAUDE report 8501875 ↗
• MalfunctionMar 16, 2019Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE POWERED OFF UNEXPECTEDLY WHILE THEY WERE USING IT ON A PATIENT IN CARDIAC ARREST. ALSO, AT ONE POINT THE DEVICE DID NOT RECOGNIZE BEING CONNECTED TO THE PATIENT THROUGH THE DEFIBRILLATION ELECTRODES. THE PATIENT INVOLVED IN THE REPORTED EVENT IS DECEASED. THE CUSTOMER ADVISED PHYSIO-CONTROL THAT THE USE OF THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE OUTCOME OF THE PATIENT BECAUSE THE PATIENT WAS ALREADY IN CARDIAC ARREST AND WAS IN ASYSTOLE. THE MONITOR SHUT OFF DURING CPR AND IMMEDIATELY CAME RIGHT BACK ON.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8426660 ↗
• MalfunctionMar 5, 2019Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE POWERED ITSELF OFF SEVERAL TIMES DURING PATIENT USE. THEY WERE ABLE TO POWER THE DEVICE BACK ON EACH TIME. 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 8392918 ↗
• MalfunctionMar 3, 2019Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE UNEXPECTEDLY POWERED OFF MULTIPLE TIMES WHILE THEY WERE ATTEMPTING TO USE IT ON A PATIENT. 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 8384979 ↗
• MalfunctionJan 30, 2019Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THE SERVICE INDICATOR WAS PRESENT ON THEIR DEVICE. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED ISSUE. UPON EVALUATION OF THE CUSTOMER'S DEVICE, PHYSIO-CONTROL OBSERVED THAT THE DEVICE IS UNABLE TO DEFIBRILLATE ABOVE 15 JOULES. THE DEVICE WOULD CHARGE; HOWEVER WHEN PRESSING THE SHOCK BUTTON, THE DEVICE WOULD NOT DELIVER DEFIBRILLATION ENERGY.

  Patient problems: No Patient Involvement

  MAUDE report 8291417 ↗
• MalfunctionJan 3, 2019Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THEIR DEVICE WAS UNABLE TO POWER ON. THE CUSTOMER ADVISED THAT THEY REPLACED THE BATTERIES IN THE DEVICE BUT THAT DID NOT RESOLVE THE ISSUE. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8212096 ↗
• MalfunctionDec 19, 2018Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE DID NOT POWER ON WHEN PROMPTED. 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 8182013 ↗