AutoPulse® Resuscitation System 100Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,136 adverse event reports that list this exact device (DI 00849111000017), received between Aug 11, 2015 and Sep 23, 2026 — classified as 6 injuries, 1,130 malfunctions.

The most frequently reported specific device problem is “Visual Prompts will not Clear” (744 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 1,136 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Visual Prompts will not Clear

  The customer reported the AutoPulse Platform (SN: (b)(6) displayed "System Error, Out of Service, Revert to Manual CPR". Also, the bottom back case is cracked. This was noticed during a regular check. No patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50870650 ↗
• MalfunctionMar 6, 2026Use of Device Problem

  DURING PREVENTATIVE MAINTENANCE ON FEBRUARY 11, 2026, THE AUTOPULSE PLATFORM (SN (B)(6)) FAILED LOAD CELL CHARACTERIZATION CHECK. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24533497 ↗
• MalfunctionMar 3, 2026Visual Prompts will not Clear

  DURING SHIFT CHECK, THE AUTOPULSE PLATFORM (B)(6) DISPLAYED FAULT 41 (PATIENT TEMPERATURE SENSOR FAILURE) UPON POWER-ON AND DID NOT CLEAR. THE CUSTOMER ATTEMPTED TO CLEAR THE FAULT BY REPLACING THE LIFEBAND AND CHECKING WHETHER THE VENTS WERE FREE OF OBSTRUCTIONS, BUT THE FAULT PERSISTED. THE PLATFORM WAS PLACED ON THE HARD SURFACE WHEN THE FAULT OCCURRED. THE CUSTOMER USUALLY KEEPS THE AUTOPULSE PLATFORM IN THE LAB FIXED TO THE PORTABLE ZOLL STAND WHEN NOT IN CLINICAL USE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24503383 ↗
• MalfunctionFeb 25, 2026Erratic or Intermittent Display; Display or Visual Feedback Problem; Unexpected Shutdown

  DURING PREVENTATIVE MAINTENANCE AT THE ZOLL SERVICE DEPOT, THE AUTOPULSE PLATFORM (SN (B)(6)) AUTOMATICALLY SWITCHED OFF AFTER BEING SWITCHED ON. ADDITIONALLY, THE BACKLIGHT FOR THE LCD SCREEN OCCASIONALLY FAILED TO FUNCTION, AS IT WOULD FLICKER BRIEFLY WHEN THE PLATFORM WAS SWITCHED ON AND THEN GO DARK AFTERWARDS. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24449690 ↗
• MalfunctionJan 28, 2026Visual Prompts will not Clear; Noise, Audible

  THE CUSTOMER REPORTED THE AUTOPULSE PLATFORM (SN (B)(6)) EMITTED A LOUD CLICK AND DISPLAYED "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR." THE DEVICE IS NOT ABLE TO RESET. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24205789 ↗
• MalfunctionJan 27, 2026Visual Prompts will not Clear

  THE CUSTOMER REPORTED THAT DURING DAILY CHECK, THE AUTOPULSE PLATFORM (SN (B)(6) SHOWED USER ADVISORY 07 (DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE) AND WAS NOT FUNCTIONING. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24196510 ↗
• MalfunctionJan 14, 2026Use of Device Problem

  AS REPORTED, THE AUTOPULSE PLATFORM (SN (B)(6) WOULD NOT RETRACT THE LIFEBAND. 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 24076634 ↗
• MalfunctionDec 30, 2025Visual Prompts will not Clear; Visual Prompts will not Clear

  THE CUSTOMER REPORTED THAT THE AUTOPULSE PLATFORM (SN (B)(6) DISPLAYED USER ADVISORY 45 (NOT AT "HOME" POSITION AFTER POWER-ON/RESTART). ZOLL TECH SUPPORT PERSONNEL PROVIDED THE CUSTOMER WITH THE INSTRUCTIONS FOR CLEARING UA45. 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 23920710 ↗
• MalfunctionDec 30, 2025Visual Prompts will not Clear; Visual Prompts will not Clear

  AS REPORTED, 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. 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 23920627 ↗
• MalfunctionDec 23, 2025Use of Device Problem; Visual Prompts will not Clear; Use of Device Problem; Visual Prompts will not Clear

  THE CUSTOMER REPORTED THE AUTOPULSE PLATFORM (SN (B)(6)) DISPLAYED USER ADVISORY (UA) 45 (NOT AT "HOME" POSITION AFTER POWER-ON/RESTART) MESSAGE THAT COULD NOT BE CLEARED. THE DRIVE SHAFT IS HARD TO TURN. THIS WAS NOTICED DURING SHIFT CHECK. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23885576 ↗
• MalfunctionDec 15, 2025Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING THE SHIFT CHECK, THE AUTOPULSE PLATFORM (SN (B)(6) DISPLAYED A USER ADVISORY (UA) 02 (COMPRESSION TRACKING ERROR) ERROR MESSAGE. THE PLATFORM WAS TESTED WITH MULTIPLE LIFEBANDS, BUT THE ERROR MESSAGE PERSISTS. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23812574 ↗
• MalfunctionNov 19, 2025Visual Prompts will not Clear; Visual Prompts will not Clear

  THE LOANER AUTOPULSE PLATFORM (SN (B)(6)) WAS USED TO RESUSCITATE A PATIENT. THE LIFEBAND WAS POSITIONED CORRECTLY, AND AN ATTEMPT WAS MADE TO START THE AUTOPULSE PLATFORM. THE PLATFORM WOULD NOT START AND SHOWED A MESSAGE ON THE LCD. THE EXACT DETAILS OF THE MESSAGE ARE UNKNOWN, BUT IT INDICATED AN ISSUE WITH THE PATIENT'S POSITIONING. THE PATIENT APPEARED CENTERED BUT WAS REPOSITIONED TO ENSURE PROPER ALIGNMENT ON THE DEVICE. THE LIFEBAND WAS CHECKED TO CONFIRM IT WAS NOT TWISTED. THE CUSTOMER WAS UNABLE TO GET THE AUTOPULSE PLATFORM TO OPERATE. THE CREW REMOVED THE LIFEBAND, AND MANUAL CHEST COMPRESSIONS CONTINUED. HOWEVER, THE RESUSCITATION WAS UNSUCCESSFUL, AND THE PATIENT WAS PRONOUNCED DEAD. ACCORDING TO THE CUSTOMER, THE DEATH WAS NOT RELATED TO THE AUTOPULSE DEVICE. PER THE CUSTOMER, THE OBSERVED ISSUE WAS NOT REPLICATED AFTER THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23597440 ↗
• MalfunctionNov 17, 2025Use of Device Problem; Use of Device Problem

  INITIALLY, THE CUSTOMER HAD REQUESTED LOGS FROM THE AUTOPULSE PLATFORM (SN: (B)(6) TO BE REVIEWED BY ZOLL SERVICE WITHOUT REPORTING ANY MALFUNCTION. UPON FOLLOW-UP ON (B)(6) 2025, THE CUSTOMER PROVIDED ADDITIONAL INFORMATION STATING THAT THE AUTOPULSE PLATFORM (SN: (B)(6) MALFUNCTIONED DURING USE ON A 72-YEAR-OLD MALE PATIENT IN CARDIAC ARREST. THE REPORTER DESCRIBED THE TREATMENT AS PROLONGED RESUSCITATION, BUT THEY DIDN'T KNOW WHETHER THE PLATFORM HAD DISPLAYED ANY ERROR MESSAGES. THE ISSUE DID NOT REPLICATE FOLLOWING THE EVENT. MANUAL CPR WAS ADMINISTERED WHEN THE MALFUNCTION OCCURRED. NO CONSEQUENCES OR IMPACTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23577673 ↗
• MalfunctionOct 28, 2025Use of Device Problem; Fitting Problem; Use of Device Problem; Fitting Problem

  THE CUSTOMER REPORTED THAT DURING DEVICE CHECKS, THEY OBSERVED THAT ONE SIDE OF THE LIFEBAND DOES NOT SECURELY CLIP INTO THE AUTOPULSE PLATFORM (SN (B)(6)). THEY TRIED INSTALLING A DIFFERENT LIFEBAND, BUT THE SAME PROBLEM OCCURRED. THE AUTOPULSE PLATFORM APPEARS TO FUNCTION PROPERLY WHEN USED WITH A MANIKIN. ZOLL TERRITORY MANAGER (REPRESENTATIVE) CHECKED THE PLATFORM'S LOCKING TABS AND COULD NOT SEE ANY DAMAGE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23408402 ↗
• MalfunctionOct 15, 2025Display Difficult to Read; Display or Visual Feedback Problem; Output Problem; Display Difficult to Read; Display or Visual Feedback Problem; Output Problem

  DURING SERVICING OF THE AUTOPULSE PLATFORM (SN (B)(6) AT THE ZOLL SERVICE DEPOT, THE PLATFORM FAILED THE LOAD CELL CHARACTERIZATION TEST, AND THE LCD SCREEN WAS NOTED TO BE FLICKERING AND UNREADABLE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23295699 ↗
• MalfunctionSep 16, 2025Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING PREVENTATIVE MAINTENANCE ON 08/26/25, THE AUTOPULSE PLATFORM (SN (B)(6) DISPLAYED USER ADVISORY (UA) 45 (NOT AT "HOME" POSITION AFTER POWER-ON/RESTART) ERROR MESSAGE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23069735 ↗
• MalfunctionSep 15, 2025Visual Prompts will not Clear; Visual Prompts will not Clear

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23058298 ↗
• MalfunctionSep 10, 2025Use of Device Problem; Use of Device Problem

  THE CUSTOMER REPORTED THE AUTOPULSE PLATFORM (SN (B)(6) STOPPED WORKING ON A 67-YEAR-OLD MALE PATIENT AND REQUIRED FREQUENT RESETS IN ORDER TO PERFORM CHEST COMPRESSIONS. WHEN THE CREW ENTERED THE TRAILER WHERE THE PATIENT WAS LOCATED, THE AUTOPULSE PLATFORM WAS ALREADY IN THE TRAILER. MANUAL CPR HAD ALREADY BEEN PERFORMED FOR 10 MINUTES PRIOR TO DEPLOYMENT OF THE PLATFORM. ONCE THE AUTOPULSE WAS DEPLOYED, IT SEEMED TO OPERATE NORMALLY FOR A VERY SHORT PERIOD OF TIME UNTIL IT WAS PAUSED TO ASSESS THE PATIENT'S RHYTHM ON THE MONITOR AND TO CHECK FOR A PULSE. WHEN THE CREW TRIED TO RESTART THE PLATFORM, IT DISPLAYED A "PULL UP LIFEBAND AND PRESS RESTART" MESSAGE. UPON FOLLOWING THE INSTRUCTIONS, THE LIFEBAND WOULD TIGHTEN BUT THE SAME MESSAGE OF "PULL UP LIFEBAND AND PRESS RESTART" WAS DISPLAYED AGAIN. THIS WAS ATTEMPTED 3 TIMES BEFORE TURNING THE DEVICE OFF AND BACK ON THEN TRYING AGAIN TO RESET THE LIFEBAND AND RESTART COMPRESSIONS. THE AUTOPULSE DID NOT DISPLAY ANY ERROR CODES DURING THE EVENT. THIS CYCLE CONTINUED SEVERAL TIMES, INTERRUPTING CONSISTENT MECHANICAL COMPRESSIONS AND ULTIMATELY REQUIRING FREQUENT PROVIDER INTERVENTION TO MAINTAIN OPERATION. AFTER MULTIPLE TROUBLESHOO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23020854 ↗
• MalfunctionAug 28, 2025Visual Prompts will not Clear; Visual Prompts will not Clear

  THE AUTOPULSE PLATFORM (SN (B)(6)) WAS USED TO RESUSCITATE A 29-YEAR-OLD FEMALE PATIENT (WEIGHT: 60 KG) WHO EXPERIENCED A CARDIAC ARREST IN THE EMERGENCY DEPARTMENT. THE CAUSE OF THE CARDIAC ARREST WAS TTP (THROMBOTIC THROMBOCYTOPENIC PURPURA) INDUCED PULMONARY HEMORRHAGE. DURING THE RESUSCITATION, THE AUTOPULSE PLATFORM STOPPED FUNCTIONING AND SHOWED A "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR" MESSAGE AFTER PERFORMING A SIGNIFICANT NUMBER OF COMPRESSIONS. THE CREW REVERTED TO MANUAL CPR FOR 20 MINUTES. HOWEVER, ROSC (RETURN OF SPONTANEOUS CIRCULATION) WAS NOT ACHIEVED, AND THE PATIENT WAS PRONOUNCED DEAD. THE MEDICS DO NOT BELIEVE THE DEVICE FAILURE CAUSED THE WORST OUTCOME. THE CUSTOMER ATTEMPTED TO EXTRACT EVENT LOGS, BUT THE PLATFORM WAS UNABLE TO CONNECT. THEY ALSO TESTED THE PLATFORM WITH ANOTHER FULLY CHARGED BATTERY, BUT THE SYSTEM ERROR PERSISTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22913513 ↗
• MalfunctionAug 26, 2025Use of Device Problem; Use of Device Problem

  THE AUTOPULSE PLATFORM (SN (B)(6)) WAS USED TO ATTEMPT RESUSCITATION OF A 53-YEAR-OLD MALE PATIENT IN CARDIAC ARREST. A STAFF MEMBER IN THE CARDIAC CATH LAB (CCL) WITNESSED THE CARDIAC ARREST, WHICH WAS ATTRIBUTED TO AN ACUTE MYOCARDIAL INFARCTION. THE PATIENT WAS IN CARDIAC ARREST FOR SECONDS BEFORE RECEIVING THE FIRST MANUAL CPR, WHICH WAS PERFORMED BY THE CCL STAFF FOR TWO MINUTES. THE CUSTOMER REPORTED THAT THE AUTOPULSE PLATFORM APPEARED TO BE FUNCTIONING BUT WAS NOT COMPRESSING ENOUGH. ACCORDING TO THE CUSTOMER, THE AUTOPULSE PLATFORM DID NOT DISPLAY ANY USER ADVISORY OR FAULT CODES. THE CREW SWITCHED TO A LUCAS/STRYKER DEVICE, WHICH WORKED AND APPLIED MORE PRESSURE. MANUAL CPR WAS PERFORMED FOR APPROXIMATELY TWO MINUTES UNTIL THE LUCAS DEVICE WAS EMPLOYED. DESPITE THESE EFFORTS, RETURN OF SPONTANEOUS CIRCULATION (ROSC) WAS NOT ACHIEVED, AND THE PATIENT WAS PRONOUNCED DEAD IN THE CATH LAB. THE CUSTOMER STATED THAT THEY CANNOT RULE OUT THE POSSIBILITY THAT THE PATIENT'S DEATH MAY HAVE BEEN RELATED TO THE ZOLL AUTOPULSE SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22899048 ↗
• MalfunctionAug 18, 2025Visual Prompts will not Clear; Visual Prompts will not Clear

  THE CUSTOMER REPORTED THAT THE AUTOPULSE PLATFORM (B)(6) DISPLAYED USER ADVISORY (UA) 45 (NOT AT "HOME" POSITION AFTER POWER-ON/RESTART) ERROR MESSAGE. THE CUSTOMER FOLLOWED ZOLL'S INSTRUCTIONS TO CLEAR THE UA45 ADVISORY WITH NO SUCCESS. THE EXACT TIME THE PROBLEM OCCURRED IS UNKNOWN. HOWEVER, PATIENT USE INFORMATION WAS REQUESTED, BUT NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 22825195 ↗
• MalfunctionAug 15, 2025Visual Prompts will not Clear; Visual Prompts will not Clear

  THE CUSTOMER REPORTED THAT DURING SHIFT CHECK, THE AUTOPULSE PLATFORM (SN (B)(6) DISPLAYED THE "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR" ERROR MESSAGE. THE CUSTOMER STORES THE PLATFORM ON THE EMERGENCY EQUIPMENT RACK IN THE EMERGENCY DEPARTMENT (ER). NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22822269 ↗
• MalfunctionAug 11, 2025Use of Device Problem; Use of Device Problem

  THE CUSTOMER REPORTED THAT THE AUTOPULSE PLATFORM (SN (B)(6)) PROVIDED INADEQUATE COMPRESSION DURING PATIENT RESUSCITATION. THE CUSTOMER EXPRESSED UNCERTAINTY ABOUT WHETHER THE PLATFORM WAS APPLYING THE PROPER PRESSURE. THEIR END TIDAL MEASUREMENTS DO NOT INDICATE THE EXPECTED CARDIAC OUTPUT, AND AS A RESULT, THEY HAVE DISCONTINUED USING THE PLATFORM. MANUAL CPR WAS PERFORMED TO CONTINUE THE RESUSCITATION. NO CONSEQUENCES OR IMPACTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22778752 ↗
• MalfunctionAug 8, 2025Use of Device Problem; Use of Device Problem

  THE CUSTOMER REPORTED THAT THE AUTOPULSE PLATFORM (SN (B)(6) PROVIDED INADEQUATE COMPRESSION DURING PATIENT RESUSCITATION. THE CUSTOMER EXPRESSED UNCERTAINTY ABOUT WHETHER THE PLATFORM WAS APPLYING THE PROPER PRESSURE. THEIR END TIDAL MEASUREMENTS DO NOT INDICATE THE EXPECTED CARDIAC OUTPUT, AND AS A RESULT, THEY HAVE DISCONTINUED USING THE PLATFORM. MANUAL CPR WAS PERFORMED TO CONTINUE THE RESUSCITATION. NO CONSEQUENCES OR IMPACTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22757437 ↗
• MalfunctionAug 4, 2025Visual Prompts will not Clear; Visual Prompts will not Clear

  THE ZOLL FIELD TECHNICIAN CONDUCTED AN ONSITE ASSESSMENT AND NOTED AN AUTOPULSE PLATFORM WITH A TAG STATING: "SYSTEM ERROR, DISPLAY BURN-IN; DOES NOT OPERATE. OOS". THE AUTOPULSE PLATFORM (SN (B)(6)) DISPLAYED A "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR" ERROR MESSAGE. THE DEVICE IS NON-OPERATIONAL AND OUT OF SERVICE (OOS). IN ADDITION, THE DISPLAY OF THE PLATFORM WAS BURNED IN. 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 22697335 ↗

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