LIFEPAK 12 defibrillator/monitorRecalls & reported problems across all models
Physio-Control, Inc. · 19 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 71
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 19 models of LIFEPAK 12 defibrillator/monitor by Physio-Control, Inc. in the FDA's device registry (GUDID). Together they are named in 71 adverse event reports in the FDA's MAUDE database, received between Aug 28, 2018 and Apr 8, 2024 — classified as 71 malfunctions.
The most frequently reported specific device problem is “Unexpected Shutdown” (21 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported LIFEPAK 12 defibrillator/monitor problems
Device problems
- Unexpected Shutdown21
- Failure to Power Up14
- Electrical /Electronic Property Problem13
- Failure to Deliver Shock/Stimulation6
- Device Sensing Problem5
- Inappropriate/Inadequate Shock/Stimulation3
- Charging Problem2
- Connection Problem2
Patient problems
- No Patient Involvement35
- No Known Impact Or Consequence To Patient31
- No Clinical Signs, Symptoms or Conditions5
LIFEPAK 12 defibrillator/monitor models
19 models, most reported first. Each model has its own page with its reports, recalls and device details.
- LIFEPAK® 12 defibrillator/monitor 99400Automated external defibrillators (non-wearable)20 reports
- LIFEPAK® 12 defibrillator/monitor 99400Automated external defibrillators (non-wearable)12 reports
- LIFEPAK® 12 defibrillator/monitor 99400Automated external defibrillators (non-wearable)8 reports
- LIFEPAK® 12 defibrillator/monitor 97400Automated external defibrillators (non-wearable)5 reports
- LIFEPAK® 12 defibrillator/monitor 99400Automated external defibrillators (non-wearable)5 reports
- LIFEPAK® 12 defibrillator/monitor 99400Automated external defibrillators (non-wearable)3 reports
- LIFEPAK® 12 defibrillator/monitor 97400Automated external defibrillators (non-wearable)3 reports
- LIFEPAK® 12 defibrillator/monitor 99400Automated external defibrillators (non-wearable)3 reports
- LIFEPAK® 12 defibrillator/monitor 99400Automated external defibrillators (non-wearable)2 reports
- LIFEPAK® 12 defibrillator/monitor 99400Automated external defibrillators (non-wearable)1 report
- LIFEPAK® 12 defibrillator/monitor 99400Automated external defibrillators (non-wearable)1 report
- LIFEPAK® 12 defibrillator/monitor 99400Automated external defibrillators (non-wearable)1 report
- LIFEPAK® 12 defibrillator/monitor 99400Automated external defibrillators (non-wearable)1 report
- LIFEPAK® 12 defibrillator/monitor 99400Automated external defibrillators (non-wearable)1 report
- LIFEPAK® 12 defibrillator/monitor 99400Automated external defibrillators (non-wearable)1 report
- LIFEPAK® 12 defibrillator/monitor 99400Automated external defibrillators (non-wearable)1 report
- LIFEPAK® 12 defibrillator/monitor 99400Automated external defibrillators (non-wearable)1 report
- LIFEPAK® 12 defibrillator/monitor 99400Automated external defibrillators (non-wearable)1 report
- LIFEPAK® 12 defibrillator/monitor 99400Automated external defibrillators (non-wearable)1 report
Recent LIFEPAK 12 defibrillator/monitor adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionApr 8, 2024Failure to Power Up; Failure to Power Up
A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NOT POWER ON. AS A RESULT, DEFIBRILLATION 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 19057627 ↗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 ↗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 ↗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 ↗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 ↗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 ↗MalfunctionJan 15, 2020Unexpected Shutdown; Unexpected Shutdown
THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE UNEXPECTEDLY SHUT DOWN WITHOUT SWITCHING TO THE SECOND BATTERY. IN THIS STATE THE DEVICE WOULD BE INOPERABLE AND DEFIBRILLATION THERAPY WOULD NOT BE AVAILABLE IF NEEDED THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE PATIENT OUTCOME REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9593868 ↗MalfunctionNov 4, 2019Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation
PHYSIO-CONTROL WAS NOTIFIED THAT THE CUSTOMER SUBMITTED A VOLUNTARY MEDWATCH (MEDSUN) FORM. (REFERENCE UF/IMPORTER REPORT # (B)(4)). THE CUSTOMER REPORTED THE FOLLOWING, ¿STAFF REPORTED THAT DEFIBRILLATOR CHARGED TO 200 JOULES BUT DID NOT DELIVER SHOCK. ANOTHER DEFIBRILLATOR USED TO SHOCK PATIENT." THE MEDWATCH FORM DID NOT INDICATE AN ADVERSE PATIENT OUTCOME.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9276121 ↗MalfunctionNov 1, 2019Failure to Power Up; Failure to Power Up
THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WOULD NOT RECOGNIZE BATTERIES AND FAILED TO POWER UP. THERE WAS NO PATIENT USE REPORTED WITH THE EVENT.
Patient problems: No Patient Involvement
MAUDE report 9267896 ↗MalfunctionOct 22, 2019Device Sensing Problem; Device Sensing Problem
THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WAS NOT DETECTING THE PADDLES LEAD. AS A RESULT, DEFIBRILLATION THERAPY MAY BE UNAVAILABLE, IF IT IS NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Patient Involvement
MAUDE report 9221725 ↗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 ↗MalfunctionSep 11, 2019Failure to Power Up; Failure to Power Up
THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE FAILED TO POWER UP. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Patient Involvement
MAUDE report 8992434 ↗
Other Physio-Control, Inc. products
- LIFEPAK 15 monitor/defibrillator93 models · 4,675 reports · 12 recalls
- LIFEPAK CR28 models · 2,307 reports
- LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors23 models · 1,382 reports · 1 recall
- LIFEPAK CR Plus and LIFEPAK Express defibrillators25 models · 396 reports
- LIFEPAK 1000 defibrillator5 models · 279 reports · 1 recall
- LIFEPAK2 models · 57 reports · 1 recall
- EDGE SYSTEM4 models · 81 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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