LIFEPAK® 12 defibrillator/monitor 99400 (REF 99400-003486)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885074855653), received between Dec 19, 2018 and Jun 13, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 13, 2023Failure to Sense; Inappropriate/Inadequate Shock/Stimulation; Failure to Sense; Inappropriate/Inadequate Shock/Stimulation

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NOT RECOGNIZE THE THERAPY CABLE BEING CONNECTED AND HAD DISPLAYED ABNORMAL ENERGY MESSAGE. 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 17119397 ↗
• MalfunctionMar 28, 2019Device Sensing Problem; Device Sensing Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEY WERE USING THIS DEVICE ON A PATIENT AND THE ECG THROUGH THE PADDLES LEAD WAS DISTORTED, WHICH MADE IT DIFFICULT FOR THEM TO ACCURATELY IDENTIFY THE PATIENT'S RHYTHM. AS A RESULT, DEFIBRILLATION THERAPY MAY HAVE BEEN DELAYED OR UNAVAILABLE, IF IT WAS NEEDED. 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 8462130 ↗
• MalfunctionFeb 12, 2019Failure to Charge; Failure to Charge

  THE CUSTOMER, A BIOMEDICAL ENGINEER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WAS UNABLE TO COMPLETE A CHARGE CYCLE FOR DEFIBRILLATION, THEREFORE ENERGY DELIVERY WOULD NOT BE AVAILABLE IF NEEDED. THE CUSTOMER ADVISED THAT THE DEVICE WOULD START THE CHARGING CYCLE, HOWEVER THE CHARGE TONE WOULD CONTINUE AND THE CHARGE CYCLE WOULD NOT COMPLETE. A BACKUP DEVICE WAS AVAILABLE AND WAS USED TO SHOCK THE PATIENT. THE CUSTOMER ADVISED THAT THERE WERE NO ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE REPORTED ISSUE. 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 8331737 ↗
• MalfunctionDec 21, 2018Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE HAD DISPLAYED A "SERVICE" MESSAGE IN ITS DISPLAY. THIS MESSAGE CAN BE INDICATIVE OF A DEVICE LOCK-UP CONDITION. AS A RESULT, DEFIBRILLATION THERAPY MAY NOT BE AVAILABLE, IF IT IS NEEDED. THERE WERE NO REPORTS OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8191559 ↗
• MalfunctionDec 19, 2018Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE POWERED OFF BY ITSELF DURING A PATIENT EVENT. THE DEVICE HAD TWO BATTERIES INSTALLED IN THE DEVICE WHEN THIS ISSUE OCCURRED. THE CUSTOMER INDICATED THAT THE DEVICE PROMPTED TO REPLACE BATTERY #2 AND THEN 10-15 SECONDS LATER THE DEVICE POWERED OFF. THE PARAMEDIC REMOVED BATTERY #2 AND TURNED THE DEVICE BACK ON AND THE DEVICE WORKED PROPERLY WITH ONLY BATTERY #1 INSTALLED. THE CUSTOMER DID NOT KNOW THE LEVEL OF CHARGE FOR EACH BATTERY, BUT STATED THAT THE BATTERY #1 DID NOT DISPLAY A LOW BATTERY PROMPT. THE CUSTOMER ADVISED THAT THERE WERE NO ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE REPORTED ISSUE. PHYSIO-CONTROL HAS MADE MULTIPLE ATTEMPTS TO CONTACT THE CUSTOMER FOR FURTHER INFORMATION ON THE EVENT AND PATIENT, BUT HAS BEEN UNSUCCESSFUL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8178637 ↗