AutoPulse®Resuscitation System 100 (REF 8700-0700-01-66)Recalls & reported problems

Summary

The FDA's MAUDE database contains 250 adverse event reports that list this exact device (DI 00849111000277), received between Aug 27, 2015 and Mar 18, 2026 — classified as 1 injury, 249 malfunctions.

The most frequently reported specific device problem is “Visual Prompts will not Clear” (160 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 250 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 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." NO FURTHER INFORMATION WAS PROVIDED. 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 24634538 ↗
• MalfunctionJan 30, 2026Use of Device Problem

  DURING SERVICING, THE LOANER AUTOPULSE PLATFORM (SN (B)(6) WAS FOUND TO HAVE A DAMAGED ENCODER SHAFT THAT COULD IMPACT DEVICE FUNCTIONALITY. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24225983 ↗
• MalfunctionDec 5, 2025Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING THE DEVICE CHECK, THE AUTOPULSE PLATFORM (SN (B)(6) DISPLAYED "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR" WITH MULTIPLE BATTERIES. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23725757 ↗
• MalfunctionJul 14, 2025Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING THE SHIFT CHECK, THE AUTOPULSE PLATFORM (SN (B)(6) REPEATEDLY DISPLAYED THE "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR" MESSAGE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22503386 ↗
• MalfunctionMay 6, 2025Visual Prompts will not Clear; Visual Prompts will not Clear

  THE CUSTOMER REPORTED THAT DURING A DEVICE INSPECTION, THEY OBSERVED THAT THE AUTOPULSE PLATFORM (SN (B)(6)) DISPLAYED "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR." NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21972874 ↗
• MalfunctionApr 28, 2025Visual Prompts will not Clear; Visual Prompts will not Clear

  CUSTOMER REPORTED THAT THE AUTOPULSE PLATFORM (SN (B)(6) DISPLAYED "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR " AND USER ADVISORY (UA) 12 (LIFEBAND NOT PRESENT). THE LIFEBAND WAS REPLACED TO TROUBLESHOOT THE ISSUE, BUT THE ERROR MESSAGES PERSISTED. 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 21916680 ↗
• MalfunctionJan 29, 2025Visual Prompts will not Clear; Visual Prompts will not Clear

  THE CUSTOMER REPORTED THAT THE AUTOPULSE PLATFORM (SN (B)(6)) DISPLAYED A USER ADVISORY 45 (NOT AT "HOME" POSITION AFTER POWER-ON/RESTART) MESSAGE. THE CUSTOMER CLEARED THE UA BY FOLLOWING THE INSTRUCTION SHEET EMAILED BY ZOLL PERSONNEL. 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 21270136 ↗
• MalfunctionDec 27, 2024Use of Device Problem; Visual Prompts will not Clear; Use of Device Problem; Visual Prompts will not Clear

  ON (B)(6) 2024, THE CREW RESPONDED TO A 67-YEAR-OLD MALE CARDIAC ARREST. THE 240 LB., APPROXIMATELY 6-FOOT-TALL PATIENT WAS FOUND IN CARDIAC ARREST BY HIS WIFE, WHO STARTED MANUAL CPR, WHICH WAS CONTINUED BY NORTH SALT LAKE POLICE DEPARTMENT. THE WIFE PERFORMED CPR FOR 2-3 MINUTES BEFORE CREW ARRIVAL. THE PATIENT WAS WHEELCHAIR BOUND AND HAD SIGNIFICANT CARDIAC HISTORY. THE CUSTOMER ARRIVED ON THE SCENE AND BEGAN WORKING THIS PATIENT. THE AUTOPULSE PLATFORM (SN (B)(6) WAS PLACED UNDER THE PATIENT, THE LIFEBAND WAS POSITIONED CORRECTLY, AND THE PLATFORM WAS STARTED. ONCE IT WAS GOING, THE CREW TRIED TO SWITCH IT FROM THE 30:2 TO THE CONTINUOUS MODE. THE "CONTINUOUS MODE" WORDS WOULD CHANGE AND LOOKED LIKE IT WAS WORKING, BUT IT FAILED TO CHANGE, AND THAT PLATFORM WOULD REVERT BACK TO THE 30:2 MODE. THE CUSTOMER WAS NEVER ABLE TO GET IT INTO CONTINUOUS MODE. AFTER ABOUT THREE MINUTES OF CPR, THE AUTOPULSE SUDDENLY STOPPED, AND IT STATED TO PULL OUT THE LIFEBAND AND PRESS CONTINUE. THESE PROMPTS WERE FOLLOWED, AND THE PLATFORM CONTINUED TO WORK FOR ABOUT 3 TO 4 MINUTES BEFORE IT DID IT AGAIN. ONCE AGAIN, THE CREW FOLLOWED THE PROMPTS, AND THE AUTOPULSE BEGINS TO WORK, BUT ONLY FOR ABO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21030480 ↗
• MalfunctionNov 15, 2024Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING SHIFT CHECK, THE AUTOPULSE PLATFORM (SN (B)(6)) DISPLAYED "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR." NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20700737 ↗
• MalfunctionNov 13, 2024No Display/Image; No Display/Image

  DURING SHIFT CHECK, THE CUSTOMER OBSERVED THAT HALF OF THE AUTOPULSE PLATFORM'S LCD SCREEN (B)(6) WAS BLANK. THE CUSTOMER IS UNSURE IF THE AUTOPULSE PLATFORM WAS DROPPED. ANOTHER BATTERY WAS USED, BUT THE ISSUE PERSISTED. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20679469 ↗
• MalfunctionMar 19, 2024Visual Prompts will not Clear; Visual Prompts will not Clear

  THE CUSTOMER REPORTED THE AUTOPULSE PLATFORM SN (B)(6) DISPLAYED "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR" ERROR MESSAGE DURING A PATIENT EVENT. THE CUSTOMER SWITCHED TO MANUAL CPR DURING THE EVENT. THE CREW SWAPPED ANOTHER AUTOPULSE PLATFORM TO COMPLETE THE SERVICE. NO ADDITIONAL INFORMATION WAS PROVIDED. PATIENT'S STATUS INFORMATION WAS REQUESTED BUT THE CUSTOMER DID NOT PROVIDE A RESPONSE.

  Patient problems: Insufficient Information

  MAUDE report 18938061 ↗
• MalfunctionDec 22, 2023Use of Device Problem; Use of Device Problem

  THE CUSTOMER REPORTED DURING SHIFT CHECK, THE BATTERY PORT OF THE AUTOPULSE PLATFORM SN (B)(6) WAS BENT WHEN THE AUTOPULSE LI-ION BATTERY SN (B)(6) WAS REMOVED. THE BATTERY HAD BEEN JAMMED INTO THE DEVICE. THE BATTERY WAS STUCK, AND THE CUSTOMER SENT THE PLATFORM TO THEIR CLINICAL ENGINEERING DEPARTMENT FOR REMOVAL. THEY ARE UNSURE IF THE PLATFORM CAN BE POWERED ON WITH THE DAMAGED BATTERY. NO PATIENT INVOLVEMENT. PLEASE SEE THE FOLLOWING RELATED MFR REPORT: FOR THE AUTOPULSE LI-ION BATTERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18384905 ↗
• MalfunctionAug 9, 2023Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING SHIFT CHECK, THE LOANER AUTOPULSE PLATFORM (B)(6). DISPLAYED USER ADVISORY (UA) 07 (DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE). NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17495118 ↗
• MalfunctionMar 3, 2023Use of Device Problem; Visual Prompts will not Clear; Use of Device Problem; Visual Prompts will not Clear

  DURING SERVICING ON (B)(6) 2023, THE AUTOPULSE PLATFORM (SN (B)(4)) DISPLAYED USER ADVISORY (UA)45 (NOT AT "HOME" POSITION AFTER POWER-ON/RESTART) AND UA02 (COMPRESSION TRACKING ERROR) MESSAGES. IN ADDITION, THE LOAD CELL READING KEPT FLUCTUATING. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16480935 ↗
• MalfunctionJan 13, 2023Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING PATIENT USE ON (B)(6) 2022, THE AUTOPULSE PLATFORM (SN (B)(4)) DISPLAYED A "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR" ERROR MESSAGE. NO ADDITIONAL INFORMATION OR PATIENT INFORMATION WAS PROVIDED. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16157866 ↗
• MalfunctionOct 5, 2022Visual Prompts will not Clear; Visual Prompts will not Clear

  AS REPORTED, THE AUTOPULSE PLATFORM (SN (B)(4)) DISPLAYED "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR" UPON POWERING UP. THE CUSTOMER REBOOTED THE PLATFORM AND REPLACED THE BATTERY BUT THE ISSUE WAS NOT RESOLVED. 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 15541555 ↗
• MalfunctionSep 30, 2022Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING SHIFT CHECK, THE AUTOPULSE PLATFORM (SN (B)(4) DISPLAYED "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR". NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15517426 ↗
• MalfunctionAug 27, 2022Visual Prompts will not Clear; Visual Prompts will not Clear

  WHEN THE CUSTOMER POWERED ON THE AUTOPULSE PLATFORM (S/N (B)(4) BEFORE DEPLOYING IT ON A CARDIAC ARREST PATIENT, THE PLATFORM DISPLAYED "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR". THE EMS CREW PERFORMED MANUAL CPR AFTER THE SYSTEM ERROR HAPPENED. THE CUSTOMER REPORTED THAT RETURN OF SPONTANEOUS CIRCULATION (ROSC) WAS NOT ACHIEVED, AND THE PATIENT WAS LATER PRONOUNCED DEAD. THE CUSTOMER DID NOT PROVIDE INFORMATION REGARDING THE RELATIONSHIP BETWEEN THE DEATH AND THE ALLEGED MALFUNCTION. HOWEVER, ZOLL'S MEDICAL SAFETY ASSESSMENT (MSA) EVALUATED THE INCIDENT, AND IT WAS DETERMINED THAT THE DEATH WAS NOT RELATED TO THE AUTOPULSE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15307761 ↗
• MalfunctionJul 6, 2022Visual Prompts will not Clear; Visual Prompts will not Clear

  THE AUTOPULSE PLATFORM (S/N (B)(4) WAS USED TO RESUSCITATE A PATIENT IN CARDIAC ARREST. WHEN THE AUTOPULSE WAS POWERED ON, THE PLATFORM DISPLAYED A "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR" ERROR MESSAGE. MANUAL CPR WAS PERFORMED AND CONTINUED THROUGHOUT THE CALL. RETURN OF SPONTANEOUS CIRCULATION (ROSC) WAS NOT ACHIEVED, AND THE PATIENT WAS PRONOUNCED DEAD. AS PER THE CUSTOMER, THE PATIENT'S DEATH WAS NOT RELATED TO THE AUTOPULSE SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14941024 ↗
• MalfunctionMay 2, 2022Visual Prompts will not Clear; Visual Prompts will not Clear

  WHEN REPLACING THE LIFEBAND DURING THE SHIFT CHECK, THE AUTOPULSE PLATFORM (B)(4) STOPPED AFTER PERFORMING A FEW COMPRESSIONS. UPON RESTARTING, THE AUTOPULSE PLATFORM DISPLAYED USER ADVISORY (UA) 45 (NOT AT "HOME" POSITION AFTER POWER-ON/RESTART). FOLLOWING UA45, THE AUTOPULSE PLATFORM CONTINUED TO SWITCH FROM ONE UA TO ANOTHER (UA19 (MAX APPLIED LOAD EXCEEDED) OR UA12 (LIFEBAND NOT PRESENT), OR UA06 (MAX BATTERY TEMPERATURE EXCEEDED) MESSAGES). THE CUSTOMER WAS ABLE TO CLEAR THE ERROR MESSAGES WITH THE HELP OF THE ZOLL TECH SUPPORT PERSONNEL VIA PHONE. THE AUTOPULSE PLATFORM WAS PLACED BACK IN SERVICE FOR CLINICAL USE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14258312 ↗
• MalfunctionMay 21, 2021Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING THE SHIFT CHECK, THE AUTOPULSE PLATFORM (SN (B)(4) ) DISPLAYED USER ADVISORY (UA) 45 (DRIVESHAFT NOT AT "HOME" POSITION AFTER POWER-ON/RESTART) AND USER ADVISORY (UA) 12 (LIFEBAND NOT PRESENT) ERROR MESSAGES. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11867779 ↗
• MalfunctionMay 17, 2021Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING SERVICING OF THE AUTOPULSE PLATFORM (S/N (B)(4)) PERFORMED AT ZOLL, THE PLATFORM FAILED FINAL TESTING DUE TO A FAULT CODE 16 (TIMEOUT MOVING TO TAKE-UP POSITION) ERROR MESSAGE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11838901 ↗
• MalfunctionMay 6, 2021Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING SHIFT CHECK, THE AUTOPULSE PLATFORM (SN (B)(4). DISPLAYED USER ADVISORY (UA) 18 (MAX TAKE-UP REVOLUTIONS EXCEEDED) ERROR MESSAGE. THE USER PERFORMED TROUBLESHOOTING BY PULLING UP THE LIFEBAND AND WAS UNABLE TO CLEAR THE UA 18 ERROR MESSAGE. FOLLOWING THIS, THE USER REPLACED LIFEBAND AND STILL UNABLE TO CLEAR THE UA 18 ERROR MESSAGE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11787848 ↗
• MalfunctionMay 6, 2021Use of Device Problem; Use of Device Problem

  DURING SERVICE ON (B)(6) 2021, THE RETURNED LOANER AUTOPULSE PLATFORM (SN (B)(4)) FAILED THE LOAD CELL CHARACTERIZATION CHECK. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11782112 ↗
• MalfunctionMay 2, 2021Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING DEPLOYMENT FOR PATIENT USE, THE AUTOPULSE PLATFORM (SN (B)(4) ) DISPLAYED "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR" ERROR MESSAGE UPON POWER ON. FOLLOWING THIS, THE CREW IMMEDIATELY PERFORM MANUAL CPR. NO CONSEQUENCES OR IMPACT TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11758711 ↗

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