AutoPulse®Resuscitation System 100 (REF 8700-0740-08)Recalls & reported problems

Summary

The FDA's MAUDE database contains 241 adverse event reports that list this exact device (DI 00849111001038), received between Dec 10, 2015 and Mar 30, 2026 — classified as 1 injury, 240 malfunctions.

The most frequently reported specific device problem is “Visual Prompts will not Clear” (150 reports).

1 other recall cover devices cleared under the same FDA submission (K112998); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 25 most recent of 241 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Visual Prompts will not Clear

  THE CUSTOMER REPORTED THAT THE AUTOPULSE PLATFORM (SN (B)(6)) DISPLAYED "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR." THE CUSTOMER HAS NOT PROVIDED ANY FURTHER INFORMATION. IT IS UNKNOWN WHEN THE PROBLEM OCCURRED. HOWEVER, PATIENT USE INFORMATION WAS REQUESTED, BUT NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 24709138 ↗
• MalfunctionMar 26, 2026Visual Prompts will not Clear

  DURING THE DEVICE CHECK, THE AUTOPULSE PLATFORM (B)(6) DISPLAYED FAULT 41 (PATIENT TEMPERATURE SENSOR FAILURE) UPON POWERING ON. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24706933 ↗
• MalfunctionFeb 12, 2026Failure to Power Up; Power Problem; Intermittent Loss of Power

  THE CUSTOMER REPORTED THAT THE AUTOPULSE NXT PLATFORM (SN (B)(6) COULD NOT BE SWITCHED ON, AND AT TIMES, IT POWERED ON AND OFF AUTOMATICALLY. THE NXT PLATFORM WAS PLACED UNDER THE PATIENT IN PREPARATION FOR USE FOLLOWING THE RETURN OF SPONTANEOUS CIRCULATION (ROSC). SPONTANEOUS CIRCULATION WAS MAINTAINED, AND THEREFORE, THE PLATFORM WAS NOT REQUIRED TO PERFORM RESUSCITATION AT ANY TIME. THE PLATFORM WAS SWITCHED ON NORMALLY WHILE POSITIONED UNDER THE PATIENT, AND IT WAS AT THAT TIME THAT THE FAULT OF AUTOMATICALLY POWERING OFF AND ON WAS FIRST OBSERVED. NO CONSEQUENCES OR IMPACTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24328091 ↗
• MalfunctionJan 29, 2026Visual Prompts will not Clear

  THE CUSTOMER REPORTED THAT THE AUTOPULSE PLATFORM (B)(6) DISPLAYED USER ADVISORY 20 (POSITION OUT OF RANGE). IT IS UNKNOWN WHEN THE PROBLEM OCCURRED. HOWEVER, PATIENT USE INFORMATION WAS REQUESTED, BUT NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 24215865 ↗
• MalfunctionJan 26, 2026Visual Prompts will not Clear

  DURING PREVENTATIVE MAINTENANCE, THE AUTOPULSE PLATFORM (SN (B)(6) FAILED INITIAL FUNCTIONAL TESTING DUE TO USER ADVISORY (UA) 07 (DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE) MESSAGE DISPLAYED UPON POWERING ON. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24185435 ↗
• MalfunctionJan 6, 2026Use of Device Problem

  DURING PREVENTATIVE MAINTENANCE ON (B)(6) 2025, IT WAS OBSERVED THAT THE GREEN START BUTTON OF THE AUTOPULSE PLATFORM (SN (B)(6) WAS DEFECTIVE AND ONLY WORKS WHEN IT IS PRESSED FIRMLY. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23985537 ↗
• MalfunctionNov 26, 2025Output Problem; Output Problem

  DURING PREVENTATIVE MAINTENANCE ON (B)(6) 2025 AT ZOLL GERMANY SERVICE DEPOT, THE AUTOPULSE PLATFORM (B)(6) FAILED THE LOAD CELL CHARACTERIZATION TEST DURING FUNCTIONAL TESTING. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23659265 ↗
• MalfunctionNov 13, 2025Display Difficult to Read; Display or Visual Feedback Problem; Display Difficult to Read; Display or Visual Feedback Problem

  DURING PREVENTATIVE MAINTENANCE ON (B)(6) 2025 OF THE RETURNED AUTOPULSE PLATFORM (SN (B)(6) AT ZOLL GERMANY SERVICE DEPOT, THE PLATFORM FAILED FUNCTIONAL TESTING BECAUSE THE DISPLAY IS UNREADABLE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23550296 ↗
• MalfunctionOct 23, 2025Use of Device Problem; Use of Device Problem

  DURING PREVENTATIVE MAINTENANCE, THE AUTOPULSE PLATFORM (SN (B)(6)) FAILED THE LOAD CELL CHARACTERIZATION TEST. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23376015 ↗
• MalfunctionOct 23, 2025Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING PREVENTATIVE MAINTENANCE AT THE ZOLL GERMANY SERVICE DEPOT, THE AUTOPULSE PLATFORM (SN: (B)(6) FAILED FUNCTIONAL TESTING WITH FAULT CODE 16 (TIMEOUT MOVING TO TAKE-UP POSITION). NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23375840 ↗
• MalfunctionOct 21, 2025Use of Device Problem; Use of Device Problem

  DURING PREVENTATIVE MAINTENANCE (PM) PERFORMED AT ZOLL, THE AUTOPULSE PLATFORM (SN (B)(6) FAILED FUNCTIONAL TESTING DUE TO THE MALFUNCTIONING FAN. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23354323 ↗
• MalfunctionSep 12, 2025Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING PREVENTATIVE MAINTENANCE, THE AUTOPULSE PLATFORM (SN (B)(6) FAILED FUNCTIONAL TESTING DUE TO FAULT 41 (PATIENT TEMPERATURE SENSOR FAILURE). NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23043182 ↗
• MalfunctionSep 11, 2025Use of Device Problem; Use of Device Problem

  THE CUSTOMER REPORTED THAT DURING RESUSCITATION, THE AUTOPULSE PLATFORM (SN (B)(6) STOPPED PERFORMING COMPRESSIONS SEVERAL TIMES, ACCOMPANIED BY A LOUD NOISE. THE LIFEBAND WAS REPLACED, AND THE PATIENT'S POSITION WAS ADJUSTED, BUT THE ISSUE CONTINUED. THE CREW SWITCHED TO MANUAL CPR, WHICH WAS ASSESSED AS HIGH QUALITY. THE MANUAL CPR CONTINUED TO BE PERFORMED IN THE HOSPITAL UPON ARRIVAL. DESPITE THESE EFFORTS, THE PATIENT DID NOT SURVIVE. THE CUSTOMER DID NOT PROVIDE INFORMATION REGARDING THE RELATIONSHIP BETWEEN THE DEATH AND THE ALLEGED MALFUNCTION. HOWEVER, THE MSA EVALUATED THE INCIDENT, AND IT WAS DETERMINED THAT THE DEATH WAS NOT RELATED TO THE AUTOPULSE DEVICE. THE CUSTOMER MENTIONED THAT THE REPORTED ISSUE WAS REPLICATED AT THE STATION AFTER THE CALL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23033715 ↗
• MalfunctionSep 3, 2025Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING PREVENTATIVE MAINTENANCE ON AUGUST 14, 2025, AT THE ZOLL GERMANY SERVICE DEPOT, THE AUTOPULSE PLATFORM (SN (B)(6)) DISPLAYED USER ADVISORY 45 (NOT AT "HOME" POSITION AFTER POWER-ON/RESTART) UPON POWERING UP. THE DRIVESHAFT COULD NOT BE ADJUSTED TO ITS "HOME" POSITION TO CLEAR THE UA45 ADVISORY. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22956914 ↗
• MalfunctionAug 28, 2025Use of Device Problem; Use of Device Problem

  WHILE MOVING THE PATIENT FROM THE AMBULANCE TO THE HOSPITAL BAY, HOSPITAL STAFF PULLED UP THE LIFEBAND (LOT#: UNKNOWN), WHICH REMAINED CONNECTED TO THE AUTOPULSE PLATFORM (SN: (B)(6). THIS ACTION CAUSED THE LIFEBAND CLIP TO BREAK OFF INSIDE THE DRIVE SHAFT. ACCORDING TO THE VEHICLE CREW, THE DEVICE WAS NOT PERFORMING CHEST COMPRESSIONS WHEN THIS ISSUE OCCURRED. AFTER THE PATIENT WAS TRANSFERRED, THE HOSPITAL STAFF SWITCHED TO MANUAL CPR. NO CONSEQUENCES OR IMPACT TO THE PATIENT. THE ISSUE WAS IDENTIFIED IMMEDIATELY AFTER THE TRANSFER OF THE PATIENT WAS COMPLETED, DURING THE PROCESS OF RESTORING THE DEVICE'S OPERATIONAL READINESS. AS A RESULT OF THE LIFEBAND CLIP BREAK, THE NEW LIFEBAND COULD NOT BE INSTALLED ON THE PLATFORM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22910770 ↗
• MalfunctionJul 28, 2025Use of Device Problem; Use of Device Problem

  DURING PREVENTATIVE MAINTENANCE (PM) ON (B)(6) 2025, THE AUTOPULSE PLATFORM (SN: (B)(6) FAILED THE LOAD CELL CHARACTERIZATION TEST. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22637442 ↗
• MalfunctionJul 8, 2025Erratic or Intermittent Display; Display or Visual Feedback Problem; Erratic or Intermittent Display; Display or Visual Feedback Problem

  WHEN STARTING UP, THE DISPLAY OF THE AUTOPULSE PLATFORM (SN (B)(6) SHOWS HIEROGLYPHS. WHEN THE DEVICE IS TURNED OFF AND ON AGAIN, THE ERROR OFTEN CANNOT BE FIXED. THE ERROR DOES NOT ALWAYS OCCUR. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22440498 ↗
• MalfunctionJun 2, 2025Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING SCHEDULED PREVENTATIVE MAINTENANCE CONDUCTED BY A DISTRIBUTOR, THE AUTOPULSE PLATFORM (SN (B)(6)) DISPLAYED FAULT CODE 41 (PATIENT TEMPERATURE SENSOR FAILURE). PER THE REPORTER, THE DEVICE HAD BEEN STORED IN A CUSTOMER AMBULANCE, PRIMARILY WITHIN A HEATED AND TEMPERATURE-CONTROLLED ENVIRONMENT. THE FAULT OCCURRED WHILE THE PLATFORM WAS PLACED ON A HARD SURFACE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22121822 ↗
• MalfunctionMay 14, 2025Mechanical Problem; Mechanical Jam; Mechanical Problem; Mechanical Jam

  DURING THE FINAL ACCEPTANCE TEST OF THE AUTOPULSE PLATFORM (SN (B)(6)) AT ZOLL ON MAY 02, 2025, AS PART OF THE SERVICE, THE SHAFT HOME POSITION COULD NOT BE ADJUSTED. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22020905 ↗
• MalfunctionApr 22, 2025Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING SHIFT CHECK, THE AUTOPULSE PLATFORM (SN: (B)(6) DISPLAYED FAULT CODE 08 (MOTOR CONTROLLER FAULT DETECTED). NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21886715 ↗
• MalfunctionApr 18, 2025Display or Visual Feedback Problem; Visual Prompts will not Clear; Display or Visual Feedback Problem; Visual Prompts will not Clear

  THE CUSTOMER REPORTED THAT DURING PATIENT USE, THE AUTOPULSE PLATFORM (SN: (B)(6) OPERATED WITHOUT ISSUES FOR ABOUT 20 MINUTES BEFORE THE LIFEBAND (LOT#: 197739) UNEXPECTEDLY TORE OFF. SUBSEQUENTLY, AN ERROR MESSAGE APPEARED ON THE PLATFORM. THE CUSTOMER MENTIONED THAT THE DISPLAY SCREEN'S LIGHT WAS DEFECTIVE (DARK) BUT STILL READABLE. HOWEVER, THEY COULDN'T RECALL THE ERROR CODE DISPLAYED ON THE LCD SCREEN. THE TORN LIFEBAND WAS CONTAMINATED WITH THE PATIENT'S BODILY FLUIDS AND NEEDED TO BE DISPOSED OF. THE ISSUE OCCURRED ON THE WAY TO THE DESTINATION HOSPITAL, AND THE CREW IMMEDIATELY CONTINUED MANUAL RESUSCITATION. RESUSCITATION WAS BRIEFLY INTERRUPTED TO UNLOAD THE STRETCHER FROM THE AMBULANCE. NO CONSEQUENCES OR IMPACTS ON THE PATIENT. AFTER THE CALL, THE CUSTOMER ATTEMPTED TO PUT THE AUTOPULSE PLATFORM BACK INTO OPERATION. TO DO THIS, THEY HAD TO REMOVE THE REMAINS OF THE TORN LIFEBAND FROM THE SHAFT. THE CUSTOMER STATED THAT THE LIFEBAND HAD APPARENTLY TORN ON THE SHAFT OF THE PLATFORM, WHERE THE BAND IS SEWN AND GLUED. THE ADHESIVE ON THE LIFEBAND'S BLACK HINGED BELT GUARDS (SKIRTS) THAT ARE THREADED INTO THE SHAFT WAS NO LONGER IN GOOD CONDITION, AND THE SEAM COULD NOT WIT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21867996 ↗
• MalfunctionFeb 26, 2025Use of Device Problem; Unexpected Shutdown; Use of Device Problem; Unexpected Shutdown

  THE CUSTOMER RECEIVED A REPORT OF AN UNCONSCIOUS PATIENT AND ATTEMPTED TO RESUSCITATE THE PATIENT USING THE AUTOPULSE PLATFORM (SN (B)(6). EN ROUTE, THE CUSTOMER WAS INFORMED THAT BYSTANDERS HAD INITIATED TELEPHONE-BASED CPR. UPON THE ARRIVAL OF THE EMERGENCY SERVICES, THE CREW FOUND THE PATIENT LYING IN THE GARDEN, HAVING BEEN RESUSCITATED FOR ABOUT 7 MINUTES. THE CREW TOOK OVER THE RESUSCITATION EFFORTS, DIAGNOSED VENTRICULAR FIBRILLATION, AND APPLIED THE PATCHES. THE CREW IMMEDIATELY PLACED THE AUTOPULSE PLATFORM ON THE STRETCHER AND RESUSCITATED THE PATIENT. THE INITIAL POSITIONING ON THE PLATFORM WAS INCORRECT, AS THE PATIENT'S ARMS WERE ALSO STRAPPED IN, BUT THE AUTOPULSE DID NOT DISPLAY ANY ERROR MESSAGES AND TURNED OFF. AFTER CORRECTING THE PATIENT'S POSITION, THE CREW TURNED THE AUTOPULSE BACK ON AND ATTEMPTED TO CONTINUE THE RESUSCITATION. THIS TIME, THE DEVICE COMPRESSED THE PATIENT'S CHEST 5-6 TIMES AND THEN TURNED OFF COMPLETELY, WITHOUT DISPLAYING ANY ERROR MESSAGES. THIS WAS REPEATED APPROXIMATELY 5-6 TIMES. THEREFORE, THE CREW SWITCHED TO MANUAL CPR. NO CONSEQUENCES OR IMPACTS ON THE PATIENT. UPON LATER INSPECTING THE DEVICE AFTER THE CALL, THE CUSTOMER CONFIRMED TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21473118 ↗
• MalfunctionFeb 6, 2025Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING PATIENT RESUSCITATION, THE AUTOPULSE PLATFORM (SN (B)(6) REPEATEDLY FAILED TO RECOGNIZE THE PATIENT, DISPLAYING "RESTART" INSTEAD OF "CONTINUE," AND COULD NOT INITIATE COMPRESSIONS. INITIALLY, THIS ISSUE WAS MITIGATED BY BENDING THE PATIENT'S KNEES TO INCREASE THE LUMBAR CONTACT SURFACE. HOWEVER, THE PROBLEM RECURRED AFTER EACH RHYTHM CHECK, LEADING TO DELAYS AND DIFFICULTY IN RESOLUTION. UPON REASSESSMENT IN THE AMBULANCE, THE DEVICE'S MALFUNCTION PERSISTED DESPITE VARIOUS INTERVENTIONS, INCLUDING PATIENT REPOSITIONING, RESTARTING THE AUTOPULSE PLATFORM, AND REPLACING THE BATTERY. ULTIMATELY, MANUAL CHEST COMPRESSIONS WERE PERFORMED DURING TRANSPORT TO THE HOSPITAL. THE PATIENT'S STATUS IS UNKNOWN. AFTER THE CALL, AUTOPULSE PLATFORM TESTING REVEALED NO PROBLEMS, AS IT FUNCTIONED NORMALLY WITH A RESUSCITATION MANIKIN.

  Patient problems: Insufficient Information

  MAUDE report 21329265 ↗
• MalfunctionFeb 3, 2025Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING PREVENTATIVE MAINTENANCE OF THE AUTOPULSE PLATFORM (SN (B)(6)), FUNCTIONAL TESTING COULD NOT BE PERFORMED BECAUSE THE DEVICE DISPLAYED AN EMPTY BATTERY UPON POWERING ON. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21294206 ↗
• MalfunctionJan 14, 2025Use of Device Problem; Use of Device Problem

  THE CUSTOMER REPORTED THAT THE AUTOPULSE PLATFORM (SN (B)(6)) STOPPED COMPRESSIONS DURING DEVICE CHECK. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21150459 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K112998. One submission often covers many models, so check the product and lot details in each record.

• Z-0118-2023 · Sep 22, 2022 · Open, Classified
  AutoPulse Li-ion Battery used on the AutoPulse Resuscitation System Model 100. used as an adjunct to manual CPR