LIFEPAK® 1000 defibrillator 99425 (REF 99425-000023)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00885074698878), received between Apr 2, 2018 and Dec 14, 2022 — classified as 1 death, 13 malfunctions.

The most frequently reported specific device problem is “Inappropriate/Inadequate Shock/Stimulation” (3 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 14, 2022Failure to Sense; Failure to Sense

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE FAILED TO DETECT A SHOCKABLE RHYTHM. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15980347 ↗
• MalfunctionJun 29, 2020Power Problem; Power Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT A NON-CRITICAL ISSUE WITH THEIR DEVICE. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT. UPON EVALUATION BY PHYSIO-CONTROL, THE DEVICE FAILED TO COMPLETE THE BOOT UP CYCLE. IN THIS STATE THE DEVICE WOULD NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED.

  Patient problems: No Patient Involvement

  MAUDE report 10209944 ↗
• MalfunctionMay 28, 2020Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THE SCREEN ON THEIR DEVICE IS DISTORTED AND UNABLE TO BE USED. IN THIS STATE THE DEVICE MAY BE INOPERABLE AND DEFIBRILLATION THERAPY WOULD NOT BE AVAILABLE IF NEEDED. THERE WAS NO PATIENT USE REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10096559 ↗
• MalfunctionDec 3, 2018Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THE DISPLAY ON THEIR DEVICE WAS BLANK AND THE SERVICE LIGHT WAS ILLUMINATED. AS A RESULT, DEFIBRILLATION MAY NOT BE POSSIBLE, IF IT WERE NECESSARY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8127102 ↗
• DeathOct 23, 2018Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WOULD NOT POWER ON DURING A PATIENT EVENT. THE CUSTOMER ADVISED THAT THE BATTERY INDICATOR OF THE DEVICE WAS FLASHING BUT THE DEVICE WOULD NOT POWER ON. ANOTHER AMBULANCE UNIT WAS ON THE SCENE AND USED ANOTHER DEVICE AND WAS ABLE TO TREAT THE PATIENT. THE CUSTOMER DID NOT KNOW THE DELAY BETWEEN THE USE OF THE ORIGINAL DEVICE AND THE BACKUP DEVICE. AFTER THE EVENT WHEN THEY CUSTOMER WAS BACK AT THEIR OFFICE, THE DEVICE DISPLAYED ¿OK¿ AND THE BATTERY WAS FULLY CHARGED. THEY REMOVED THE BATTERY TO GET THE BATTERY INFORMATION, WHEN ATTEMPTING TO REINSTALL THE BATTERY THEY FELT THAT IT WAS VERY DIFFICULT TO SLIDE THE BATTERY INTO THE BATTERY COMPARTMENT. THE PATIENT, AN 81 YEAR OLD MALE DID NOT SURVIVE.

  Patient problems: Death

  MAUDE report 7996036 ↗
• MalfunctionOct 8, 2018Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  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 WAS DELIVERING MONOPHASIC ENERGY RATHER THAN BIPHASIC ENERGY. THE ENERGY DELIVERED BY THE DEVICE WAS ALSO AT A LOWER ENERGY LEVEL THAN WHAT WAS SELECTED. AS A RESULT, THE INCORRECT DEFIBRILLATION THERAPY MAY BE DELIVERED, IF IT WAS NEEDED.

  Patient problems: No Patient Involvement

  MAUDE report 7942730 ↗
• MalfunctionAug 13, 2018Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT A NON-CRITICAL ISSUE WITH THEIR DEVICE. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT. UPON EVALUATION OF THE CUSTOMER'S DEVICE, PHYSIO-CONTROL OBSERVED THAT THE DEVICE WOULD NOT POWER ON.

  Patient problems: No Patient Involvement

  MAUDE report 7778246 ↗
• MalfunctionJul 17, 2018Failure to Sense; Failure to Sense

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT DURING A CARDIAC ARREST, THEIR DEVICE WOULD NOT RECOGNIZE THAT A 55 YEAR OLD MALE WAS CONNECTED. THE CUSTOMER REPORTED THAT THE PATIENT HAD AN EXCESSIVE AMOUNT OF HAIR ON THEIR CHEST AND THEY HAD NOT COMPLETED SKIN PREP TO THE CHEST PRIOR TO ELECTRODE PLACEMENT. THE CREW BROUGHT OUT A SECOND DEVICE, WITH MINIMAL DELAY AND A NEW SET OF ELECTRODE PADS WERE ATTACHED TO THE PATIENT. THEY WERE ABLE TO DELIVER A SHOCK TO THE PATIENT; HOWEVER THE PATIENT DID NOT SURVIVE THE EVENT. THE CUSTOMER REPORTED THAT THE ISSUE WITH THEIR DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE OUTCOME OF THE PATIENT SINCE THEY WERE ABLE TO DELIVER A SHOCK TO THE PATIENT USING THEIR SECOND DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7696127 ↗
• MalfunctionJun 22, 2018Failure to Charge; Failure to Charge

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT A NON-CRITICAL FAILURE 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 WOULD NOT COMPLETE A CHARGE WHEN ATTEMPTING TO DELIVER A TEST SHOCK. THE DEVICE ALMOST REACHED FULL CHARGE WHEN AN ARC WAS HEARD. AS A RESULT, DEFIBRILLATION THERAPY WOULD NOT BE AVAILABLE, IF IT WAS NEEDED.

  Patient problems: No Patient Involvement

  MAUDE report 7629444 ↗
• MalfunctionJun 1, 2018Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THE SERVICE INDICATOR WAS ILLUMINATED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED ISSUE. UPON EVALUATION OF THE CUSTOMER'S DEVICE, PHYSIO-CONTROL OBSERVED THAT THERE IS A PARTIAL LOSS OF DEFIBRILLATOR OUTPUT ENERGY DUE TO THE LOSS OF THE NEGATIVE PORTION OF THE BIPHASIC OUTPUT WAVEFORM, RESULTING IN A MONOPHASIC SHOCK. AS A RESULT, THE WRONG DEFIBRILLATION THERAPY WOULD BE DELIVERED, IF IT WERE NECESSARY.

  Patient problems: No Patient Involvement

  MAUDE report 7562675 ↗
• MalfunctionJun 1, 2018Failure to Charge; Failure to Charge

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THE SERVICE WRENCH ICON WAS PRESENT ON 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 WAS NOT ABLE TO CHARGE TO DELIVER DEFIBRILLATION THERAPY.

  Patient problems: No Patient Involvement

  MAUDE report 7562517 ↗
• MalfunctionMay 8, 2018Power Problem; Power Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE HAD DEPLETED MULTIPLE BATTERIES RAPIDLY DESPITE NO USAGE. AS A RESULT, THE POWER SOURCE (BATTERY) COULD BE PREMATURELY DEPLETED WHICH MAY DELAY, OR PREVENT, DEFIBRILLATION IF IT WERE NECESSARY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7495281 ↗
• MalfunctionApr 23, 2018Failure to Deliver Energy; Failure to Deliver Energy

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE DID NOT SHOCK WHEN THEY ATTEMPTED TO SHOCK WHILE USING IT ON A PATIENT. THE CUSTOMER WAS USING INFANT/CHILD REDUCED ENERGY ELECTRODES. THE CUSTOMER SWITCHED THE INFANT/CHILD ELECTRODES WITH STANDARD ELECTRODES AND WERE ABLE TO SHOCK THE PATIENT USING THE STANDARD ELECTRODES. THERE WERE NO REPORTS OF 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; HOWEVER, THE CUSTOMER ADVISED THAT NO FURTHER DETAILS ARE AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7452995 ↗
• MalfunctionApr 2, 2018Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE DISPLAYED THE SERVICE INDICATOR AND WAS ALARMING. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT. UPON EVALUATING THE CUSTOMER'S DEVICE, PHYSIO OBSERVED A FAILURE THAT RESULTED IN A PARTIAL LOSS OF DEFIBRILLATOR OUTPUT ENERGY DUE TO A LOSS OF THE NEGATIVE PORTION OF THE BIPHASIC OUTPUT WAVEFORM, RESULTING IN A MONOPHASIC SHOCK. AS A RESULT, THE WRONG DEFIBRILLATION THERAPY WOULD BE DELIVERED, IF IT WERE NECESSARY.

  Patient problems: No Patient Involvement

  MAUDE report 7390716 ↗