LUCAS™ CHEST COMPRESSION SYSTEM 99576 (REF 99576-000043)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00883873861875), received between Mar 2, 2019 and Mar 10, 2026 — classified as 1 injury, 14 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (9 reports).

2 FDA recall records name this device's identifier, 2 still open.

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 16, 2026.

Recalls naming this device

1. Apr 13, 2026Open, Classified

   Due to a subset of chest compression systems/devices where the service performed on the systems were not appropriately documented (The documents for the service performed to justify the passing results were not include in the service records).

   Z-2161-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. May 21, 2025Open, Classified

   Due to demonstration units of chest compression system being provided to a customer which may potentially be utilized for clinical use.

   Z-1998-2025 · Root cause: Employee error · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 10, 2026Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE ALARMED AND PAUSED DURING INTERVENTION ON A PATIENT. IN THIS STATE THE DEVICE WOULD NOT BE ABLE TO PERFORM AUTOMATED CHEST COMPRESSIONS. IF A DEVICE MALFUNCTIONS, THE DEVICE OPERATING INSTRUCTIONS INDICATE THAT THE USER IS TO REMOVE THE DEVICE AND IMMEDIATELY START MANUAL CHEST COMPRESSIONS. THERE WAS NO ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24556188 ↗
• MalfunctionMar 2, 2026Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE STOPPED COMPRESSIONS AND ALARMED. IN THIS STATE, A DELAY IN CARDIOPULMONARY RESUSCITATION MAY OCCUR. IF A DEVICE MALFUNCTIONS, THE DEVICE OPERATING INSTRUCTIONS INDICATE THAT THE USER IS TO REMOVE THE DEVICE AND IMMEDIATELY START MANUAL CHEST COMPRESSIONS. THERE WAS NO HARM TO THE PATIENT AS A RESULT OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24478454 ↗
• MalfunctionFeb 25, 2026Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NO LONGER PERFORM COMPRESSIONS. IF A DEVICE MALFUNCTIONS, THE DEVICE OPERATING INSTRUCTIONS INDICATE THAT THE USER IS TO REMOVE THE DEVICE, AND IMMEDIATELY START MANUAL CHEST COMPRESSIONS. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24442525 ↗
• MalfunctionFeb 4, 2026Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE ALARMED AND PAUSED. IN THIS STATE, A DELAY IN CARDIOPULMONARY RESUSCITATION MAY OCCUR. IF A DEVICE MALFUNCTIONS, THE DEVICE OPERATING INSTRUCTIONS INDICATE THAT THE USER IS TO REMOVE THE DEVICE AND IMMEDIATELY START MANUAL CHEST COMPRESSIONS. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24256245 ↗
• MalfunctionFeb 3, 2026Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NOT PROVIDE AUTOMATIC CHEST COMPRESSIONS. IN THIS STATE THE DEVICE WOULD NOT BE ABLE TO PERFORM AUTOMATED CHEST COMPRESSIONS, IF NEEDED. IF A DEVICE MALFUNCTIONS, THE DEVICE OPERATING INSTRUCTIONS INDICATE THAT THE USER IS TO REMOVE THE DEVICE AND IMMEDIATELY START MANUAL CHEST COMPRESSIONS. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24246936 ↗
• MalfunctionFeb 2, 2026Mechanical Jam

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NOT PERFORM COMPRESSIONS. IF A DEVICE MALFUNCTIONS, THE DEVICE OPERATING INSTRUCTIONS INDICATE THAT THE USER IS TO REMOVE THE DEVICE AND IMMEDIATELY START MANUAL CHEST COMPRESSIONS. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24242388 ↗
• MalfunctionJan 30, 2026Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WAS CATCHING IN THE UP POSITION DURING USE. IN THIS STATE THE DEVICE WOULD NOT BE ABLE TO PERFORM AUTOMATED CHEST COMPRESSIONS, IF NEEDED. IF A DEVICE MALFUNCTIONS, THE DEVICE OPERATING INSTRUCTIONS INDICATE THAT THE USER IS TO REMOVE THE DEVICE AND IMMEDIATELY START MANUAL CHEST COMPRESSIONS. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24221739 ↗
• MalfunctionJan 27, 2026Mechanical Jam

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WILL NOT PERFORM COMPRESSIONS. IN THIS STATE, A DELAY IN CARDIOPULMONARY RESUSCITATION MAY OCCUR. IF A DEVICE MALFUNCTIONS, THE DEVICE OPERATING INSTRUCTIONS INDICATE THAT THE USER IS TO REMOVE THE DEVICE AND IMMEDIATELY START MANUAL CHEST COMPRESSIONS. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24191572 ↗
• MalfunctionJan 26, 2026Key or Button Unresponsive/not Working

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT CONTROLS ON THEIR DEVICE ARE UNRESPONSIVE. IN THIS STATE, A DELAY IN CARDIOPULMONARY RESUSCITATION MAY OCCUR. IF A DEVICE MALFUNCTIONS, THE DEVICE OPERATING INSTRUCTIONS INDICATE THAT THE USER IS TO REMOVE THE DEVICE AND IMMEDIATELY START MANUAL CHEST COMPRESSIONS. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24180196 ↗
• MalfunctionJan 6, 2026Detachment of Device or Device Component

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THE SUPPORT LEGS ON THEIR LUCAS COMPRESSION DEVICE WAS OVERSPREAD. THIS MAY PROHIBIT THE DEVICE FROM LOCKING SECURELY TO THE BACKPLATE OF THE DEVICE. IF A DEVICE MALFUNCTIONS, THE DEVICE OPERATING INSTRUCTIONS INDICATE THAT THE USER IS TO REMOVE THE DEVICE AND IMMEDIATELY START MANUAL CHEST COMPRESSIONS. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23983964 ↗
• MalfunctionDec 19, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE ALARMED AND PAUSED. IN THIS STATE, A DELAY IN CARDIOPULMONARY RESUSCITATION MAY OCCUR. IF A DEVICE MALFUNCTIONS, THE DEVICE OPERATING INSTRUCTIONS INDICATE THAT THE USER IS TO REMOVE THE DEVICE AND IMMEDIATELY START MANUAL CHEST COMPRESSIONS. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23850481 ↗
• MalfunctionDec 17, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THEIR DEVICE ALARMED AND DID NOT WORK AS EXPECTED UPON POWERING UP. IN THIS STATE THE DEVICE WOULD NOT BE ABLE TO PERFORM AUTOMATED CHEST COMPRESSIONS. IF A DEVICE MALFUNCTIONS, THE DEVICE OPERATING INSTRUCTIONS INDICATE THAT THE USER IS TO REMOVE THE DEVICE AND IMMEDIATELY START MANUAL CHEST COMPRESSIONS. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23825623 ↗
• MalfunctionDec 17, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THEIR DEVICE ALARMS AND DOES NOT GET INTO THE READY POSITION UPON START UP. IN THIS STATE THE DEVICE WOULD NOT BE ABLE TO PERFORM AUTOMATED CHEST COMPRESSIONS. IF A DEVICE MALFUNCTIONS, THE DEVICE OPERATING INSTRUCTIONS INDICATE THAT THE USER IS TO REMOVE THE DEVICE AND IMMEDIATELY START MANUAL CHEST COMPRESSIONS. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23825617 ↗
• InjuryMay 3, 2019Use of Device Problem; Use of Device Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE HAD POTENTIALLY CAUSED A LIVER BLEED DURING A RESUSCITATION. AN ECHO HAD BEEN PERFORMED DURING THE EVENT, FOR WHICH GEL HAD BEEN APPLIED TO THE PATIENT'S CHEST. THE GEL HAD BEEN LEFT ON THE PATIENT'S CHEST WHEN THE DEVICE WAS APPLIED. NO STABILIZATION STRAPS COULD BE DEPLOYED, BECAUSE OF OTHER ACTIVITIES. DURING THE USE IT WAS OBSERVED THAT THE DEVICE HAD TO BE MOVED FURTHER UP THE CHEST TO A MORE SUPERIOR POSITION ON THE STERNUM. SUBSEQUENTLY, THE HEALTHCARE PROVIDER STILL FELT THE POSITION WASN'T HIGH ENOUGH. A DECISION WAS THEN MADE THAT IT WOULD BE DETRIMENTAL TO STOP COMPRESSION. THE LIVER BLEED WAS DISCOVERED AFTER THE RESUSCITATION AND THE PATIENT WAS PROVIDED WITH FURTHER TREATMENT. THE PATIENT SURVIVED THE REPORTED EVENT.

  Patient problems: Liver Laceration(s)

  MAUDE report 8579682 ↗
• MalfunctionMar 2, 2019Leak/Splash; Leak/Splash

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR LUCAS 3 BATTERY EMITTING AN ELECTRICAL SMELL AND THEN THE BATTERY VENTED THROUGH THE PLASTIC SHELL. THE DEVICE WAS IN A PAUSED AND ALARMED STATE. IT WAS ALSO REPORTED THAT THE DEVICE WAS WARM TO THE TOUCH WITH A NEW BATTERY INSTALLED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT. UPON EVALUATION OF THE CUSTOMER¿S BATTERY, PHYSIO-CONTROL OBSERVED EVIDENCE OF MATERIAL LEAKAGE FROM THE CELLS OF THE BATTERY. PER THE CELL MATERIAL SAFETY DATA SHEET, THESE MATERIALS INCLUDE FLAMMABLE ORGANIC SOLVENTS AND CORROSIVE IRRITANTS. THUS POTENTIAL HAZARDS INCLUDE CHEMICAL BURNS FROM CELL MATERIAL EXPOSURE TO SENSITIVE TISSUES (EYES, SKIN, RESPIRATORY, GASTRO/RESPIRATORY) AND FOR THERMAL BURNS RESULTING FROM IGNITION OF VENTED BATTERY CELL FLAMMABLE SOLVENTS.

  Patient problems: No Patient Involvement

  MAUDE report 8384307 ↗