LIFEPAK® 12 defibrillator/monitor 99400 (REF 99400-000372)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00721902148460), received between Dec 4, 2018 and Jan 29, 2020 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (2 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 29, 2020Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE FAILED TO SHOCK DURING A PATIENT EVENT. THE CUSTOMER ADVISED THAT THE DEVICE WAS ABLE TO SHOCK THE PATIENT SUCCESSFULLY ON THE FIRST SHOCK, ON THE SECOND AND THIRD SHOCK ATTEMPT, THE SHOCK WAS NOT DELIVERED. ON THE FOURTH AND FIFTH SHOCK, THE DEVICE DELIVERED THE ENERGY. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE PATIENT OUTCOME REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9643971 ↗
• MalfunctionMay 22, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT A NON-CRITICAL ISSUE WITH THEIR DEVICE. UPON EVALUATION OF THE CUSTOMER¿S DEVICE, PHYSIO-CONTROL OBSERVED THAT THE DEVICE WAS UNABLE TO COMPLETE A BOOT CYCLE. 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 8632133 ↗
• MalfunctionMay 13, 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 WITH INTERNAL PADDLES AND THE DEVICE DID NOT SHOCK THE PATIENT ON THE FIRST ATTEMPT. THEY WERE ABLE TO DELIVER 4 ADDITIONAL SHOCKS TO THE PATIENT AND THEN OBTAINED A BACKUP DEVICE. 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 8606245 ↗
• MalfunctionMay 13, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE DISPLAYED "SERVICE" ON ITS DISPLAY. THIS CAN BE INDICATIVE OF A DEVICE LOCKUP CONDITION. 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 8603769 ↗
• MalfunctionApr 15, 2019Failure to Charge; Failure to Charge

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE INTERMITTENTLY WILL NOT CHARGE. THEY ATTEMPTED TO CHARGE THE DEVICE DURING PATIENT USE AND HAD TO TURN THE DEVICE OFF AND THEN BACK ON, IN ORDER TO GET THE DEVICE TO CHARGE. 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 8516444 ↗
• MalfunctionFeb 8, 2019Energy Output Problem; Energy Output Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE IS NOT DELIVERING THE CORRECT ENERGY. NO FURTHER DETAILS WERE PROVIDED. AS A RESULT, THE INCORRECT DEFIBRILLATION THERAPY MAY BE DELIVERED TO A PATIENT, IF IT WAS NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8324273 ↗
• MalfunctionDec 12, 2018Charging Problem; Charging Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WOULD NOT CHARGE DEFIBRILLATION ENERGY AT THE SELECTED ENERGY LEVEL. THE DEVICE WOULD ONLY CHARGE TO 2 JOULES. 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 Patient Involvement

  MAUDE report 8158273 ↗
• MalfunctionDec 4, 2018Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  THE CUSTOMER, A BIOMEDICAL ENGINEER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE CHARGED TO AN INCORRECT ENERGY LEVEL. THE CUSTOMER ADVISED THAT THE DEVICE WAS CHARGED TO 200 JOULES, HOWEVER THE ENERGY CHARGE ONLY WOULD GO UP TO 50 JOULES. ADVISED THAT THEIR DEVICE SERVICE INDICATOR HAD ILLUMINATED WHEN THE DEFIBRILLATION ELECTRODES WERE CONNECTED TO THE PATIENT. IN THIS STATE, INADEQUATE OR WRONG DEFIBRILLATION THERAPY WOULD BE DELIVERED TO THE PATIENT. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE PATIENT OUTCOME REPORTED. NO FURTHER DETAILS WERE PROVIDED BY THE CUSTOMER. 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 8130746 ↗