AutoPulse®Resuscitation System 100 (REF 8700-0740-01)Recalls & reported problems
Zoll Circulation, Inc. · The AutoPulse System consists of 4 primary components, a reusable Platform, a single use chest compression assembly (LifeBand), a rechargeable battery, and a battery charger. · Class 2
All models of AutoPulseResuscitation System (46)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This ZOLL AutoPulse resuscitation system is a chest compression device used during CPR. Of its 320 reports, 317 are malfunctions, mostly describing on-screen warnings that will not clear, plus a chest compression band that snapped during CPR. The reports include 2 injuries and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 317
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 317 adverse event reports that list this exact device (DI 00849111001014), received between Sep 3, 2015 and Aug 26, 2026 — classified as 2 injuries, 314 malfunctions.
The most frequently reported specific device problem is “Visual Prompts will not Clear” (219 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.
Reports received per month
Most reported problems
Device problems
- Visual Prompts will not Clear219
- Device Displays Incorrect Message68
- Device Operational Issue58
- Device Operates Differently Than Expected27
- Use of Device Problem26
- Failure to Power Up8
- No Display/Image6
- Unexpected Shutdown4
Patient problems
- No Clinical Signs, Symptoms or Conditions117
- No Patient Involvement113
- No Known Impact Or Consequence To Patient36
- No Consequences Or Impact To Patient34
- Insufficient Information13
- Cardiac Arrest3
- Injury3
- No Information3
Recent adverse event reports
The 25 most recent of 317 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 26, 2026Visual Prompts will not Clear
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50461975 ↗MalfunctionFeb 11, 2026Output Problem
DURING PREVENTATIVE MAINTENANCE AT ZOLL SERVICE DEPOT, THE AUTOPULSE PLATFORM (SN (B)(6)) FAILED THE LOAD CELL CHARACTERIZATION TEST DURING FUNCTIONAL TESTING. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24318111 ↗MalfunctionJan 15, 2026Visual Prompts will not Clear
DURING SHIFT CHECK, THE CUSTOMER REPORTED THE AUTOPULSE PLATFORM (SN (B)(6)) DISPLAYED THE USER ADVISORY (UA) 23 (COMPRESSION WILL EXCEED 3 REVOLUTIONS) ERROR MESSAGE UPON POWERING ON THE DEVICE. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24089720 ↗MalfunctionJan 13, 2026Visual Prompts will not Clear
THE CUSTOMER SENT THEIR AUTOPULSE PLATFORM (SN (B)(6) TO THE ZOLL DISTRIBUTOR BECAUSE IT WAS DISPLAYING USER ADVISORY 45 (NOT AT "HOME" POSITION AFTER POWER-ON/RESTART). THE ZOLL DISTRIBUTOR FOLLOWED THE INSTRUCTIONS TO ROTATE THE PLATFORM'S DRIVESHAFT TO ITS "HOME" POSITION. THE UA45 WAS CLEARED, AND THE AUTOPULSE PLATFORM WAS RETURNED TO THE CUSTOMER. THE REPORTED ISSUE WAS OBSERVED DURING SHIFT CHECK. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24063325 ↗MalfunctionDec 31, 2025Visual Prompts will not Clear; Visual Prompts will not Clear
DURING DEVICE CHECK, THE AUTOPULSE PLATFORM (SN (B)(6) DISPLAYED USER ADVISORY (UA) 07 (DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE) ERROR MESSAGE. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23937565 ↗MalfunctionDec 8, 2025Visual Prompts will not Clear; Visual Prompts will not Clear
DURING TRAINING WITH THE AUTOPULSE PLATFORM (SN (B)(6), AFTER POWERING ON AND SIZING THE MANNEQUIN, THE PLATFORM PERFORMED A FEW COMPRESSIONS. IT STOPPED, DISPLAYING "PULL UP LIFEBAND, CHECK PATIENT ALIGNMENTS, AND PRESS RESTART." THE CREW TRIED READJUSTING AND REPOSITIONING THE LIFEBAND AND THE MANNEQUIN MULTIPLE TIMES, BUT THE ISSUE CONTINUED. THE VIDEO PROVIDED BY THE CUSTOMER SHOWED THAT THE AUTOPULSE PLATFORM DISPLAYED A USER ADVISORY 19 (MAX APPLIED LOAD EXCEEDED) MESSAGE. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23744908 ↗MalfunctionDec 5, 2025Visual Prompts will not Clear; Visual Prompts will not Clear
DURING SHIFT CHECK, THE AUTOPULSE PLATFORM (SN (B)(6) DISPLAYED 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 23725749 ↗MalfunctionNov 10, 2025Visual Prompts will not Clear; Visual Prompts will not Clear
THE AUTOPULSE PLATFORM (SN (B)(6)) WAS DEPLOYED FOR RESUSCITATION. UPON POWERING ON, THE AUTOPULSE PLATFORM DISPLAYED A "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR" MESSAGE. NO CONSEQUENCES OR IMPACT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23518604 ↗MalfunctionNov 4, 2025Visual 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 23472049 ↗MalfunctionOct 16, 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) 45 (NOT AT "HOME" POSITION AFTER POWER-ON/RESTART) MESSAGE. NO FURTHER INFORMATION WAS PROVIDED. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23319543 ↗MalfunctionJul 22, 2025Visual Prompts will not Clear; Visual Prompts will not Clear
DURING SHIFT CHECK, THE CUSTOMER REPORTED THAT THE AUTOPULSE PLATFORM (SN (B)(6)) DISPLAYED USER ADVISORY (UA) 02 (COMPRESSION TRACKING ERROR) ERROR MESSAGE AFTER THE FIRST COMPRESSION. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22571524 ↗MalfunctionJul 11, 2025Visual Prompts will not Clear; Visual Prompts will not Clear
THE CUSTOMER REPORTED THE 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 22486300 ↗MalfunctionJul 8, 2025Visual Prompts will not Clear; Visual Prompts will not Clear
DURING SHIFT CHECK, THE AUTOPULSE PLATFORM (SN (B)(6) DISPLAYED USER ADVISORY (UA) 45 (NOT AT "HOME" POSITION AFTER POWER-ON/RESTART). NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22443946 ↗MalfunctionJun 25, 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 22333451 ↗MalfunctionJun 5, 2025Visual Prompts will not Clear; Visual Prompts will not Clear
DURING SHIFT CHECK, THE CUSTOMER REPORTED THAT THE AUTOPULSE PLATFORM (SN (B)(6)) DISPLAYED AN UNKNOWN ERROR MESSAGE AND INTERRUPTED THE COMPRESSION. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22155379 ↗MalfunctionApr 17, 2025Visual Prompts will not Clear; Visual Prompts will not Clear
DURING THE SHIFT CHECK, THE AUTOPULSE PLATFORM (SN (B)(6) DISPLAYED THE USER ADVISORY (UA) 17 (MAX MOTOR ON-TIME EXCEEDED DURING ACTIVE OPERATION) ERROR MESSAGE AFTER MULTIPLE COMPRESSIONS. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21862559 ↗MalfunctionMar 18, 2025Use of Device Problem; Visual Prompts will not Clear; Use of Device Problem; Visual Prompts will not Clear
DURING SHIFT CHECK, THE CUSTOMER REPORTED THE AUTOPULSE PLATFORM (SN (B)(6)) STOPPED COMPRESSIONS DUE TO AN UNKNOWN ERROR MESSAGE. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21635777 ↗MalfunctionMar 13, 2025Visual Prompts will not Clear; Visual Prompts will not Clear
DURING THE SHIFT CHECK, THE AUTOPULSE PLATFORM (B)(6) REPEATEDLY FAILED AND DISPLAYED A MESSAGE OF "PULL UP LIFEBAND". NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21602094 ↗MalfunctionMar 13, 2025Visual Prompts will not Clear; Visual Prompts will not Clear
DURING THE SHIFT CHECK, THE AUTOPULSE PLATFORM (SN (B)(6)) DISPLAYED THE "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR" MESSAGE DURING THE DEVICE START-UP. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21602023 ↗MalfunctionMar 13, 2025Visual Prompts will not Clear; Visual Prompts will not Clear
DURING SHIFT CHECK, THE AUTOPULSE PLATFORM (SN (B)(6)) DISPLAYED A USER ADVISORY 17 (MAX MOTOR ON TIME EXCEEDED DURING ACTIVE OPERATION) MESSAGE AND POWERED OFF BY ITSELF REPEATEDLY. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21601987 ↗MalfunctionMar 13, 2025Use of Device Problem; Use of Device Problem
THE CUSTOMER REPORTED THAT DURING SHIFT CHECK, THE AUTOPULSE PLATFORM (SN (B)(6) DID NOT FUNCTION AS INTENDED. NO CLARIFICATION WAS PROVIDED. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21599395 ↗MalfunctionMar 11, 2025Fitting Problem; Visual Prompts will not Clear; Fitting Problem; Visual Prompts will not Clear
THE CUSTOMER REPORTED THE BACK CASING OF THE AUTOPULSE PLATFORM (SN (B)(6) THAT GOES OVER THE ROTATOR COMES AWAY FAR TOO EASILY. DURING ARREST THE OTHER DAY AND THE LIFEBAND KEPT POPPING OFF FROM THE BACK OF THE PLATFORM. IT WAS POINTED OUT THAT THE BAND IS NOT FITTING PROPERLY AND CAN EASILY BE PULLED OUT. USE OF THE PLATFORM WAS DISCONTINUED, AND A LUCAS DEVICE WAS USED. AFTER THE ARREST THE CUSTOMER TOOK THE LIFEBAND OFF, CHECKED IT WAS PLACED ON CORRECTLY AND TRIED IT ON A DUMMY AND THERE WERE NO ISSUES. NO DEVICE MALFUNCTION IS SUSPECTED FOR THE LIFEBAND. PRIOR TO THE EVENT, IN TRAINING, THEY WERE EXPERIENCING USER ADVISORY (UA) 45 (NOT AT "HOME" POSITION AFTER POWER-ON/RESTART) ERROR MESSAGES, BUT ELECTROMED DEPARTMENT REPORTED THE ERRORS APPEARED TO HAVE BEEN CLEARED. NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21579518 ↗MalfunctionJan 2, 2025Visual Prompts will not Clear; Visual Prompts will not Clear
THE CUSTOMER REPORTED DURING SHIFT CHECK, THE AUTOPULSE PLATFORM (SN (B)(6) 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 21063841 ↗MalfunctionDec 7, 2024Visual Prompts will not Clear; Visual Prompts will not Clear
DURING THE SHIFT CHECK, THE AUTOPULSE PLATFORM (SN (B)(6)) DISPLAYED A "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR' ERROR MESSAGE". NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20874253 ↗MalfunctionNov 1, 2024Visual Prompts will not Clear; Visual Prompts will not Clear
DURING SHIFT CHECK, AFTER THE CALL, THE AUTOPULSE PLATFORM (SN (B)(6) DISPLAYED USER ADVISORY (UA) 45 (NOT AT "HOME" POSITION AFTER POWER-ON/RESTART) WHEN THE USER REPLACED THE LIFEBAND. THE USER WAS NOT ABLE TO CLEAR THE USER ADVISORY. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20591305 ↗
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, ClassifiedAutoPulse Li-ion Battery used on the AutoPulse Resuscitation System Model 100. used as an adjunct to manual CPR
Other Compressor, Cardiac, External devices
- AutoPulse®Resuscitation System 100Zoll Circulation, Inc. · Compressor, Cardiac, External3,208 reports
- AutoPulse Li-ion Battery™ 100Zoll Circulation, Inc. · Compressor, Cardiac, External1,151 reports
- AutoPulse® Resuscitation System 100Zoll Circulation, Inc. · Compressor, Cardiac, External1,136 reports
- AutoPulse®Resuscitation System 100Zoll Circulation, Inc. · Compressor, Cardiac, External276 reports
- AutoPulse®Resuscitation System 100Zoll Circulation, Inc. · Compressor, Cardiac, External250 reports
- AutoPulse®Resuscitation System 100Zoll Circulation, Inc. · Compressor, Cardiac, External241 reports
- LUCAS 99576Jolife AB · Compressor, cardiac, external2 recalls9 deaths99 reports
- LifeBand® Load-distributing Band 100Zoll Circulation, Inc. · Compressor, Cardiac, External1 death199 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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