AutoPulse®Resuscitation System 100 (REF 8700-0700-02)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 is a mechanical chest compression system used during cardiac resuscitation. The 55 reports mostly describe the platform showing error messages or prompts that would not clear during shift checks and maintenance tests, plus one unit that failed to power up. None of the reports involved a patient, and there are no deaths or injuries. There are no recalls naming 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
- 54
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 00849111000116), received between Aug 11, 2015 and Dec 28, 2023 — classified as 54 malfunctions.
The most frequently reported specific device problem is “Visual Prompts will not Clear” (29 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 Clear29
- Device Displays Incorrect Message21
- Device Operational Issue8
- Device Operates Differently Than Expected6
- Device Issue1
- Device Stops Intermittently1
- Failure to Power Up1
- Fitting Problem1
Patient problems
- No Patient Involvement21
- No Known Impact Or Consequence To Patient15
- No Clinical Signs, Symptoms or Conditions9
- No Consequences Or Impact To Patient7
- Cardiac Arrest1
- No Information1
- Not Applicable1
Recent adverse event reports
The 25 most recent of 54 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 28, 2023Visual 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 18414804 ↗MalfunctionMar 1, 2023Visual Prompts will not Clear; Visual Prompts will not Clear
DURING SHIFT CHECK, CUSTOMER REPORTED THAT THE AUTOPULSE PLATFORM (SERIAL #(B)(4) DISPLAYED "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR " MESSAGE. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16461140 ↗MalfunctionOct 17, 2022Visual Prompts will not Clear; Visual Prompts will not Clear
DURING SHIFT CHECK, CUSTOMER REPORTED THAT THE AUTOPULSE PLATFORM SERIAL #(B)(4) DISPLAYED USER ADVISORY "(UA)45" (DRIVESHAFT NOT AT "HOME" POSITION AFTER POWER-ON/RESTART) ERROR MESSAGE. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15616395 ↗MalfunctionDec 3, 2021Visual Prompts will not Clear; Visual Prompts will not Clear
DURING PREVENTIVE MAINTENANCE ON (B)(6) 2021, THE AUTOPULSE PLATFORM (SN (B)(4)) FAILED FUNCTIONAL TESTING DUE TO THE 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 12930319 ↗MalfunctionJul 16, 2021Visual Prompts will not Clear; Visual Prompts will not Clear
DURING SHIFT CHECK, THE AUTOPULSE PLATFORM (SN (B)(4)) 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 12186030 ↗MalfunctionJun 12, 2021Visual Prompts will not Clear; Visual Prompts will not Clear
DURING THE SHIFT CHECK, THE AUTOPULSE PLATFORM (SN (B)(4)) DISPLAYED USER ADVISORY (UA) 07 (DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE) ERROR MESSAGE WITH A RED LED. IN ADDITION, THE CUSTOMER REPORTED THE DRIVESHAFT COULD NOT BE TURNED MANUALLY AND THE PLATFORM COVER WAS DAMAGED. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11988592 ↗MalfunctionFeb 18, 2021Visual Prompts will not Clear; Visual Prompts will not Clear
DURING SHIFT CHECK, CUSTOMER REPORTED THE AUTOPULSE PLATFORM (SERIAL #(B)(4)) DISPLAYED A USER ADVISORY - "(UA) 07" (DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE) AND THEN UA20 (POSITION OUT OF RANGE) ERROR MESSAGES UPON POWERING ON. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11346958 ↗MalfunctionDec 28, 2020Visual 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" ERROR MESSAGE. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11084916 ↗MalfunctionDec 8, 2020Visual Prompts will not Clear; Visual Prompts will not Clear
DURING THE SHIFT CHECK, THE AUTOPULSE PLATFORM (SN (B)(4)) 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 10963988 ↗MalfunctionAug 14, 2020Fitting Problem; Fitting Problem
DURING PATIENT USE, CUSTOMER REPORTED THAT THE LIFEBAND CLIP WOULD NOT FIT PROPERLY INTO THE DRIVESHAFT SLOT OF THE AUTOPULSE PLATFORM (SERIAL #(B)(4)). THE LIFEBAND HAS GONE OFF HOOK SEVERAL TIMES. NO DAMAGE WAS OBSERVED ON THE DRIVESHAFT AREA OF THE AUTOPULSE. CUSTOMER TRIED USING WITH MULTIPLE LIFEBANDS WITH NO SUCCESS. PATIENT'S STATUS INFORMATION WAS REQUESTED BUT THE CUSTOMER DID NOT PROVIDE A RESPONSE, THEREFORE PATIENT'S STATUS IS UNKNOWN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10405967 ↗MalfunctionJun 30, 2020Visual Prompts will not Clear; Visual Prompts will not Clear
WHEN THE CUSTOMER WAS TESTING THE AUTOPULSE PLATFORM (SN: (B)(4)), THE PLATFORM DISPLAYED "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR" ERROR MESSAGE. NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 10213613 ↗MalfunctionMay 5, 2020Failure to Power Up; Unexpected Shutdown; Failure to Power Up; Unexpected Shutdown
DURING THE SHIFT CHECK, THE AUTOPULSE PLATFORM POWERED OFF ON ITS OWN AFTER 3 MINUTES AND WOULDN'T POWER BACK ON. THE GOOD WORKING AUTOPULSE LI-ION BATTERY WAS USED TO POWER ON THE PLATFORM. PER THE REPORTER, NO ERROR MESSAGES WERE NOTED. IN ADDITION, THE USER OBSERVED CRACK ON THE PLATFORM'S TOP COVER NEAR THE LCD SCREEN AND NOISY PLATFORM FAN. NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 10023383 ↗MalfunctionOct 16, 2019Visual Prompts will not Clear; Visual Prompts will not Clear
DURING PATIENT USE, CUSTOMER REPORTED THAT THE AUTOPULSE PLATFORM (SERIAL (B)(4)) DISPLAYED A USER ADVISORY - "(UA) 45" (DRIVESHAFT NOT AT "HOME" POSITION AFTER POWER-ON/RESTART) ERROR MESSAGE ON THE CONTROL PANEL. THE USER WAS UNABLE TO CLEAR THE ERROR MESSAGE AND CONTINUED WITH MANUAL CPR. PATIENT DEATH WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9198644 ↗MalfunctionOct 9, 2019Use of Device Problem; Use of Device Problem
THE AUTOPULSE PLATFORM (SN (B)(4)) STOPPED AFTER PERFORMING THREE COMPRESSIONS. NO ADDITIONAL INFORMATION WAS PROVIDED. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9172456 ↗MalfunctionSep 6, 2019Visual 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" ERROR MESSAGE. NO ADDITIONAL INFORMATION WAS PROVIDED. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT INFORMATION WAS AVAILABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8971331 ↗MalfunctionJul 9, 2019Visual Prompts will not Clear; Visual Prompts will not Clear
THE AUTOPULSE PLATFORM (SN (B)(4)) DISPLAYED A "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR" MESSAGE UPON POWER UP. THE REPORTER WAS UNABLE TO SPECIFY IF THE ISSUE OCCURRED DURING SHIFT CHECK OR PATIENT USE. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8773594 ↗MalfunctionMar 14, 2019Visual Prompts will not Clear; Visual Prompts will not Clear
AS REPORTED, DURING PATIENT USE, THE AUTOPULSE PLATFORM (SN (B)(4)) STOPPED COMPRESSIONS AFTER DISPLAYING UA16 (TIMEOUT MOVING TO TAKE-UP POSITION) ERROR MESSAGE. THE USER WAS UNABLE TO RESOLVE THE ISSUE BY RESETTING OR REPLACING THE LIFEBAND. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT INFORMATION WAS AVAILABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8421181 ↗MalfunctionMar 5, 2019Visual Prompts will not Clear; Visual Prompts will not Clear
DURING PATIENT USE, THE AUTOPULSE PLATFORM (SN (B)(4)) DISPLAYED A UA (USER ADVISORY) 45 (DRIVESHAFT NOT AT "HOME" POSITION AFTER POWER-ON/RESTART) ERROR MESSAGE. USER WAS UNABLE TO CLEAR THE MESSAGE. THE REPORTER WAS UNABLE TO SPECIFY PATIENT OUTCOME. NO KNOWN IMPACT OR PATIENT CONSEQUENCE INFORMATION WAS AVAILABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8392855 ↗MalfunctionJan 30, 2019Visual Prompts will not Clear; Visual Prompts will not Clear
AS REPORTED, DURING THE DEVICE CHECK, THE AUTOPULSE PLATFORM (SN (B)(4)) DISPLAYED A SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR MESSAGE ON THE DISPLAY SCREEN. NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8291368 ↗MalfunctionJan 9, 2019Visual Prompts will not Clear; Visual Prompts will not Clear
IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT THE AUTOPULSE PLATFORM (SN (B)(4)) WIRE RESTRAINT LOOP WAS DAMAGED. THE AUTOPULSE PLATFORM WAS RETURNED TO ZOLL FOR INVESTIGATION. DURING INITIAL FUNCTIONAL TESTING, THE PLATFORM DISPLAYED A "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR" MESSAGE UPON POWER UP.
Patient problems: No Patient Involvement
MAUDE report 8232655 ↗MalfunctionDec 18, 2018No Display/Image; No Display/Image
AS REPORTED, THE AUTOPULSE PLATFORM (SN (B)(4)) SCREEN LCD DISPLAYED BLANK UPON POWERING ON. NO OTHER FUNCTIONAL ISSUE WAS REPORTED. NO PATIENT WAS INVOLVED.
Patient problems: No Patient Involvement
MAUDE report 8175597 ↗MalfunctionDec 11, 2018Visual Prompts will not Clear; Visual Prompts will not Clear
DURING PREVENTATIVE MAINTENANCE (PM) SERVICE ON THE RETURNED AUTOPULSE PLATFORM ((B)(4)), 'SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR' ERROR MESSAGE DISPLAYED ON THE SCREEN DURING THE INITIAL FUNCTIONAL TEST.
Patient problems: No Patient Involvement
MAUDE report 8153227 ↗MalfunctionOct 8, 2018Visual Prompts will not Clear; Visual Prompts will not Clear
AS REPORTED, DURING SHIFT CHECK, THE AUTOPULSE PLATFORM (SN (B)(4)) DISPLAYED A USER ADVISORY - UA27 (ENCODER FAULT) ERROR MESSAGE DURING POWER ON. NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 7945410 ↗MalfunctionSep 18, 2018Visual Prompts will not Clear; Visual Prompts will not Clear
AS REPORTED, THE AUTOPULSE PLATFORM (SN (B)(4)) DISPLAYED A USER ADVISORY - UA 45 (DRIVESHAFT NOT AT "HOME" POSITION AFTER POWER-ON/RESTART) ERROR MESSAGE ON THE SCREEN PANEL. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7886760 ↗MalfunctionAug 8, 2018Visual Prompts will not Clear; Visual Prompts will not Clear
AS REPORTED, THE USER'S AUTOPULSE PLATFORM (SN (B)(4)) DISPLAYED A USER ADVISORY - UA 45 (DRIVESHAFT NOT AT "HOME" POSITION AFTER POWER-ON/RESTART) ERROR MESSAGE ON THE CONTROL PANEL. THE USER WAS UNABLE TO CLEAR THE ERROR MESSAGE. NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 7764995 ↗
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, External317 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
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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