AutoPulse®Resuscitation System 100 (REF 8700-0730-01-66)Recalls & reported problems

Summary

The FDA's MAUDE database contains 189 adverse event reports that list this exact device (DI 00849111000772), received between Aug 30, 2015 and Nov 20, 2025 — classified as 3 injuries, 186 malfunctions.

The most frequently reported specific device problem is “Visual Prompts will not Clear” (122 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 189 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 20, 2025Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING THE SHIFT CHECK, THE AUTOPULSE PLATFORM (SN (B)(6)) DISPLAYED THE USER ADVISORY 45 (NOT AT "HOME" POSITION AFTER POWER-ON/RESTART) ERROR MESSAGE. THE CUSTOMER WAS UNABLE TO CLEAR THE UA. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23602483 ↗
• MalfunctionSep 17, 2025Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING PREVENTATIVE MAINTENANCE, THE AUTOPULSE PLATFORM (SN 30793R) FAILED FUNCTIONAL TESTING DUE TO USER ADVISORY 17 (MAX MOTOR ON TIME EXCEEDED DURING ACTIVE OPERATION). NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23077889 ↗
• MalfunctionSep 11, 2025Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING THE 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 23034111 ↗
• MalfunctionJul 1, 2025Use of Device Problem; Use of Device Problem

  AS REPORTED, THE AUTOPULSE PLATFORM (SN (B)(6)) DISPLAYED A "LIFEBAND NOT RECOGNIZED" MESSAGE. 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 22379276 ↗
• MalfunctionJun 25, 2025Visual Prompts will not Clear; Visual Prompts will not Clear

  THE CUSTOMER REPORTED DURING PATIENT USE, THE AUTOPULSE PLATFORM (SN (B)(6) DISPLAYED "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR" ERROR MESSAGE. THE PLATFORM POWERED ON AND PERFORMED COMPRESSIONS FOR ABOUT 30 SECONDS BEFORE THE ERROR WAS DISPLAYED. NO IMPACT OR CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22330568 ↗
• MalfunctionJun 17, 2025Visual Prompts will not Clear; Visual Prompts will not Clear

  THE CUSTOMER REPORTED THAT DURING SHIFT CHECK, THE AUTOPULSE PLATFORM (SN (B)(6) DISPLAYED "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR" UPON POWER UP. THE CUSTOMER RESTARTED THE PLATFORM BUT THAT DID NOT RESOLVE THE ISSUE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22248268 ↗
• MalfunctionJun 10, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  DURING THE INVESTIGATION AND SERVICING OF THE AUTOPULSE PLATFORM (SN (B)(6)), THE LOAD CELL CHARACTERIZATION TEST FAILED AND INDICATED THAT ONE OF THE LOAD CELLS WAS OVER-REPORTING. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22179866 ↗
• MalfunctionApr 25, 2025Use of Device Problem; Use of Device Problem

  DURING THE CALL, THE CUSTOMER REPORTED AN ISSUE INVOLVING THE USE OF TWO AUTOPULSE PLATFORMS ON A SINGLE PATIENT. THE FIRST AUTOPULSE PLATFORM (SN (B)(6)) INDICATED THE NEED TO REPOSITION THE PATIENT, EVEN AFTER MULTIPLE ADJUSTMENTS. UPON SWITCHING TO THE SECOND PLATFORM (SN (B)(6)), WHICH WAS A ZOLL LOANER DEVICE PROVIDED TO THE CUSTOMER, THE SYSTEM CONTINUED TO PROMPT FOR LIFEBAND REPOSITIONING DESPITE MULTIPLE ADJUSTMENT ATTEMPTS. PER THE REPORTER, THE PATIENT DID NOT SURVIVE. NO ADDITIONAL INFORMATION WAS PROVIDED. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21914455 ↗
• MalfunctionApr 22, 2025Visual Prompts will not Clear; Visual Prompts will not Clear

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21883531 ↗
• MalfunctionFeb 19, 2025Visual Prompts will not Clear; Visual Prompts will not Clear

  THE AUTOPULSE PLATFORM (SN (B)(6)) WAS USED TO RESUSCITATE A PATIENT. DURING ITS OPERATION, THE PLATFORM DISPLAYED A USER ADVISORY 07 (DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE) MESSAGE AND PROMPTED THE USER TO PULL UP THE LIFEBAND, CHECK PATIENT ALIGNMENT, AND PRESS START. THE CUSTOMER FOLLOWED THESE PROMPTS, BUT THE RED LIGHT REMAINED ON, AND THE PLATFORM DISPLAYED UA07. 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 21414603 ↗
• MalfunctionJan 26, 2025Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING A RESUSCITATION ATTEMPT, MANUAL CPR WAS PERFORMED ON A PATIENT. AN ATTEMPT WAS MADE TO USE THE AUTOPULSE PLATFORM (SN (B)(6), BUT IT DISPLAYED A MESSAGE TO "REPLACE/RECHARGE BATTERY" AND FAILED TO START WHEN THE CUSTOMER TRIED PRESSING THE RESTART BUTTON. CONSEQUENTLY, THE PATIENT REMAINED ON THE AUTOPULSE PLATFORM WHILE MANUAL CPR IMMEDIATELY CONTINUED FOR THE DURATION OF THE CODE. NO IMPACT OR CONSEQUENCE TO THE PATIENT. PER THE REPORTER, AFTER THE CALL, THE PLATFORM WAS TESTED AND DISPLAYED A "REPLACE/RECHARGE BATTERY" ERROR MESSAGE CONSISTENTLY, REGARDLESS OF THE BATTERY USED. ALL BATTERIES HAVE BEEN FULLY CHARGED USING THE AUTOPULSE CHARGER, AND THE SAME BATTERIES FUNCTION PROPERLY WITH OTHER AUTOPULSE PLATFORMS WITHOUT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21236954 ↗
• MalfunctionDec 2, 2024Use of Device Problem; Use of Device Problem

  DURING SERVICE PERFORMED AT ZOLL ON (B)(6) 2024, THE AUTOPULSE PLATFORM (B)(6) FAILED THE LOAD CELL CHARACTERIZATION TEST. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20827400 ↗
• MalfunctionNov 13, 2024Use of Device Problem; Use of Device Problem

  PATIENT #1 - DURING THE RESUSCITATION OF A PATIENT IN CARDIAC ARREST, THE AUTOPULSE PLATFORM (B)(6) FAILED TO FUNCTION. IMMEDIATELY, THE CREW REVERTED TO MANUAL CPR. NO NEGATIVE OUTCOME TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20676327 ↗
• MalfunctionNov 13, 2024Visual Prompts will not Clear; Visual Prompts will not Clear

  PATIENT #2 - DURING THE RESUSCITATION OF A PATIENT IN CARDIAC ARREST, THE AUTOPULSE PLATFORM (SN (B)(6)) DISPLAYED A USER ADVISORY 17 (MAX MOTOR ON TIME EXCEEDED DURING ACTIVE OPERATION) ERROR. IMMEDIATELY, THE CREW REVERTED TO MANUAL CPR. NO NEGATIVE OUTCOME TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20676326 ↗
• MalfunctionNov 12, 2024Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  DURING THE INVESTIGATION, THE AUTOPULSE PLATFORM ((B)(6)) FAILED THE LOAD CELL CHARACTERIZATION CHECK. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20668675 ↗
• MalfunctionNov 4, 2024Visual Prompts will not Clear; Visual Prompts will not Clear

  THE CUSTOMER REPORTED THAT THE AUTOPULSE PLATFORM (SN (B)(6) DISPLAYED "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR" DURING ROUTINE DEVICE CHECKS. THE AUTOPULSE PLATFORM WAS TESTED WITH DIFFERENT BATTERIES AND LIFEBANDS, BUT THE SYSTEM ERROR PERSISTED. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20605222 ↗
• MalfunctionOct 31, 2024Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING SERVICE, THE LOANER AUTOPULSE PLATFORM (SN (B)(6) FAILED FUNCTIONAL TESTING DUE TO FAULT 24 (TIMEOUT MOVING TO HOME POSITION). NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20582172 ↗
• MalfunctionJul 12, 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 19736203 ↗
• MalfunctionMay 24, 2024Use of Device Problem; Use of Device Problem

  THE CUSTOMER REPORTED THE AUTOPULSE LIFEBAND LOCKING TAB SLOTS ON THE AUTOPULSE PLATFORM (SN (B)(6)) WERE OBSERVED TO BE BROKEN. THE ISSUE AFFECTS THE FUNCTIONALITY OF THE PLATFORM. THE ISSUE WAS OBSERVED AFTER PATIENT USE. DURING THE CALL, THE PLATFORM PERFORMED AS INTENDED. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19397583 ↗
• MalfunctionApr 18, 2024No Display/Image; No Display/Image

  THE CUSTOMER REPORTED THAT THE LCD SCREEN OF THE AUTOPULSE PLATFORM (B)(6) WAS BLANK DURING A SHIFT CHECK. PER CUSTOMER, THE LEDS NEAR THE LCD SCREEN WERE GREEN AS EXPECTED, BUT THE DISPLAY DIDN`T SHOW ANY PARAMETERS. THE CUSTOMER TROUBLESHOT THE ISSUE BY CHANGING BATTERIES, BUT THE PROBLEM PERSISTED. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19140793 ↗
• MalfunctionApr 1, 2024Visual Prompts will not Clear; Visual Prompts will not Clear

  THE CUSTOMER REPORTED THAT UPON REPLACING THE LIFEBAND, THE AUTOPULSE PLATFORM (B)(6) DISPLAYED FAULT CODE 08 (MOTOR CONTROLLER MALFUNCTION). ADDITIONALLY, THE CUSTOMER REQUESTED ZOLL SERVICE TO PERFORM BIO-CLEANING OF THE PLATFORM. 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 19016517 ↗
• MalfunctionMar 28, 2024Display Difficult to Read; Display or Visual Feedback Problem; Display Difficult to Read; Display or Visual Feedback Problem

  THE CUSTOMER REPORTED THAT THE LCD SCREEN OF THE AUTOPULSE PLATFORM (B)(6) WAS UNREADABLE. 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; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19000558 ↗
• MalfunctionMar 26, 2024Visual Prompts will not Clear; Visual Prompts will not Clear

  WHILE TRAINING NEW EMS PROVIDERS, THE AUTOPULSE PLATFORM (B)(6) DISPLAYED A USER ADVISORY (UA) 45 (NOT AT "HOME" POSITION AFTER POWER-ON/RESTART) MESSAGE. ZOLL ADVISED THE CUSTOMER TO CLEAR THE UA45 BY FOLLOWING THE INSTRUCTIONS TO RESET THE DRIVE SHAFT. THE CUSTOMER WAS ABLE TO CLEAR THE UA45 BY FOLLOWING THE INSTRUCTIONS. HOWEVER, THE AUTOPULSE PLATFORM DISPLAYED FAULT 16 (TIMEOUT MOVING TO TAKE-UP POSITION) AFTER CLEARING UA45, AND THE FAULT CODE WOULD NOT CLEAR. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18984454 ↗
• MalfunctionFeb 29, 2024Visual Prompts will not Clear; Visual Prompts will not Clear

  THE CUSTOMER REPORTED DURING PATIENT USE, THE AUTOPULSE PLATFORM (B)(6) DISPLAYED FAULT 16 (TIMEOUT MOVING TO TAKE-UP POSITION). THE CREW SWITCHED THE PATIENT TO ANOTHER AUTOPULSE PLATFORM ON ANOTHER VEHICLE THAT ARRIVED LATER. 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 18813465 ↗
• MalfunctionFeb 29, 2024Use of Device Problem; Use of Device Problem

  DURING SERVICE ON 02/13/2024, 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 18813438 ↗

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