AutoPulse®Resuscitation System 100 (REF 8700-0700-16)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
The Zoll AutoPulse is a mechanical chest compression system used during cardiac resuscitation. Most of its 46 reports describe the unit displaying error messages or visual prompts that would not clear, plus units that would not power up or behaved differently than expected; one report mentions a skin laceration, with no deaths and one injury. 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
- 46
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 00849111000079), received between Oct 21, 2015 and Jan 23, 2025 — classified as 1 injury, 45 malfunctions.
The most frequently reported specific device problem is “Visual Prompts will not Clear” (33 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 Clear33
- Device Operational Issue6
- Use of Device Problem5
- Device Operates Differently Than Expected3
- Device Displays Incorrect Message2
- Failure to Power Up2
- Power Problem2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Patient Involvement21
- No Clinical Signs, Symptoms or Conditions15
- Insufficient Information3
- No Consequences Or Impact To Patient3
- No Known Impact Or Consequence To Patient2
- Injury1
- Laceration(s)1
Recent adverse event reports
The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 23, 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 21225757 ↗MalfunctionSep 26, 2024Use of Device Problem; Use of Device Problem
THE CUSTOMER REPORTED THE AUTOPULSE PLATFORM (SN (B)(6) IS BROKEN. NO ADDITIONAL INFORMATION IS AVAILABLE. 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 20315622 ↗MalfunctionAug 12, 2024Visual Prompts will not Clear; Visual Prompts will not Clear
AS REPORTED, THE AUTOPULSE PLATFORM (SN (B)(6) DISPLAYED A USER ADVISORY (UA) 02 (COMPRESSION TRACKING ERROR) ERROR MESSAGE. 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 19967176 ↗MalfunctionNov 8, 2023Visual Prompts will not Clear; Visual Prompts will not Clear
DURING THE SHIFT CHECK, THE AUTOPULSE PLATFORM (SN (B)(6) DISPLAYED A 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 18094535 ↗MalfunctionOct 9, 2023Use of Device Problem; Visual Prompts will not Clear; Use of Device Problem; Visual Prompts will not Clear
AS REPORTED, THE AUTOPULSE PLATFORM (SN (B)(6)) DISPLAYED A USER ADVISORY (UA) 12 (LIFEBAND NOT PRESENT) ERROR MESSAGE AND THE BAND CLIP OF THE LIFEBAND COULD NOT BE RELEASED FROM THE DRIVESHAFT. IT IS UNKNOWN WHERE THE PROBLEM OCCURRED. HOWEVER, PATIENT USE INFORMATION WAS REQUESTED BUT NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 17893064 ↗MalfunctionSep 8, 2023Visual Prompts will not Clear; Visual Prompts will not Clear
DURING SHIFT CHECK, THE AUTOPULSE PLATFORM (SN (B)(6)) DISPLAYED USER ADVISORY (UA) 07 (DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE) UPON POWERING ON. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17712207 ↗MalfunctionJun 28, 2023Visual Prompts will not Clear; Visual Prompts will not Clear
DURING SHIFT CHECK, THE AUTOPULSE PLATFORM (SN (B)(6)) DISPLAYED USER ADVISORY (UA) 07 (DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE) UPON POWERING ON. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17217732 ↗MalfunctionMar 29, 2023Visual Prompts will not Clear; Visual Prompts will not Clear
DURING PATIENT USE, THE AUTOPULSE PLATFORM (SN (B)(4)) DISPLAYED FAULT CODE 27 (ENCODER FAULT (> 3000 RPM) ERROR MESSAGE AFTER FIVE COMPRESSIONS. MANUAL CPR WAS PERFORMED. NO CONSEQUENCES OR IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16637575 ↗MalfunctionMar 2, 2023Use of Device Problem; Use of Device Problem
DURING DEVICE EVALUATION ON 8 FEB 2023, THE AUTOPULSE PLATFORM ((B)(4)) FAILED THE LOAD CELL CHARACTERIZATION TEST. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16469513 ↗MalfunctionOct 18, 2022Visual Prompts will not Clear; Visual Prompts will not Clear
DURING SHIFT CHECK, THE CUSTOMER REPORTED THAT 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 15626277 ↗MalfunctionSep 7, 2022Visual Prompts will not Clear; Visual Prompts will not Clear
DURING PATIENT USE, THE AUTOPULSE PLATFORM (SN (B)(4) DISPLAYED FAULT CODE 27 (ENCODER FAULT (> 3000 RPM)) AND USER ADVISORY "(UA)34" (ENCODER FAILURE) ERROR MESSAGES. NO CONSEQUENCES OR IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15372241 ↗MalfunctionJun 1, 2022Visual Prompts will not Clear; Visual Prompts will not Clear
DURING THE SHIFT CHECK, THE AUTOPULSE PLATFORM (SN (B)(4) DISPLAYED A "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR" MESSAGE. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14559283 ↗MalfunctionMar 29, 2022Visual Prompts will not Clear; Visual Prompts will not Clear
CUSTOMER REPORTED THE AUTOPULSE PLATFORM ((B)(4)) DISPLAYED A USER ADVISORY (UA) 07 (DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE) ERROR MESSAGE IMMEDIATELY UPON POWERING ON THAT COULD NOT BE CLEARED. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13940350 ↗MalfunctionJul 23, 2021Visual Prompts will not Clear; Visual Prompts will not Clear
DURING SHIFT CHECK, THE AUTOPULSE PLATFORM (S/N (B)(4)) DISPLAYED "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR" UPON POWERING UP. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12218920 ↗MalfunctionMay 26, 2021Visual Prompts will not Clear; Visual Prompts will not Clear
DURING THE DEVICE CHECK, THE AUTOPULSE PLATFORM (SN (B)(4) ) DISPLAYED USER ADVISORY (UA) 02 (COMPRESSION TRACKING ERROR) MESSAGE SEVERAL TIMES. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11883040 ↗MalfunctionMay 21, 2021Visual Prompts will not Clear; Visual Prompts will not Clear
DURING THE SHIFT CHECK, AFTER THE REPLACEMENT OF THE LIFEBAND AND THE BATTERY, THE AUTOPULSE PLATFORM (SN (B)(4)) DISPLAYED A "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR" ERROR MESSAGE. IN ADDITION, THE LCD BACKLIGHT WAS FUNCTIONING INTERMITTENTLY. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11867741 ↗MalfunctionMay 2, 2021Visual Prompts will not Clear; Visual Prompts will not Clear
DURING DEVICE CHECK AT CUSTOMER SITE, A ZOLL BENELUX REPRESENTATIVE OBSERVED THE AUTOPULSE PLATFORM (SERIAL #(B)(4)) DISPLAYED "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR " UPON POWERING ON. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11758706 ↗MalfunctionMar 27, 2021Visual Prompts will not Clear; Visual Prompts will not Clear
DURING THE PREVENTIVE MAINTENANCE AT THE CUSTOMER SITE, THE AUTOPULSE PLATFORM SN (B)(4) DISPLAYED USER ADVISORY (UA) 02 (COMPRESSION TRACKING ERROR) MESSAGE. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11579950 ↗MalfunctionAug 11, 2020Visual Prompts will not Clear; Visual Prompts will not Clear
DURING 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 Patient Involvement
MAUDE report 10393571 ↗MalfunctionJul 9, 2020Use of Device Problem; Use of Device Problem
DURING SHIFT CHECK, THE AUTOPULSE PLATFORM (SN (B)(4)) WILL NOT POWER ON DUE TO THE AUTOPULSE LI-ION BATTERY WAS UNABLE TO BE FULLY INSERTED IN THE BATTERY BAY. THE USER OBSERVED A BROKEN BATTERY CONNECTOR INSIDE THE BATTERY BAY. NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 10252499 ↗MalfunctionJun 11, 2020Visual Prompts will not Clear; Visual Prompts will not Clear
THE AUTOPULSE PLATFORM (SN (B)(4)) WAS RETURNED FOR THE DAMAGED FRONT ENCLOSURE OBSERVED DURING THE SHIFT CHECK. AS PART OF ROUTINE SERVICE, THE DEVICE WAS TESTED AND DURING INITIAL POWER-UP, DISPLAYED USER ADVISORY (UA) 07(DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE) ERROR MESSAGE ON THE USER CONTROL PANEL. NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 10142040 ↗MalfunctionMar 19, 2020Visual Prompts will not Clear; Visual Prompts will not Clear
THE CUSTOMER REQUESTED THE AUTOPULSE PLATFORM (SN: (B)(4)) TO BE EVALUATED AFTER THE PLATFORM WAS DROPPED BY THE STAFF DURING SHIFT CHECK. PER CUSTOMER, THE TOP COVER WAS CRACKED AFTER THE INCIDENT. DURING DEVICE EVALUATION, THE AUTOPULSE PLATFORM FAILED INITIAL FUNCTIONAL TESTING DUE TO USER ADVISORY (UA) 07 (DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE) ERROR MESSAGE.
Patient problems: No Patient Involvement
MAUDE report 9856535 ↗MalfunctionMar 13, 2020Visual Prompts will not Clear; Visual Prompts will not Clear
DURING PATIENT USE, CUSTOMER REPORTED THAT THE AUTOPULSE PLATFORM (SERIAL #30739) DISPLAYED "REALIGN PATIENT" ERROR MESSAGE. ALSO, THE BACKLIGHT ON THE LCD WAS DEFECTIVE. NO CONSEQUENCES OR IMPACT TO PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9831555 ↗MalfunctionMar 13, 2020Visual Prompts will not Clear; Visual Prompts will not Clear
DURING 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 Patient Involvement
MAUDE report 9830931 ↗MalfunctionMar 6, 2020Visual Prompts will not Clear; Visual Prompts will not Clear
DURING THE SHIFT CHECK, THE AUTOPULSE PLATFORM (SN (B)(4)) DISPLAYED USER ADVISORY (UA) 17 (MOTOR ON FOR TOO LONG DURING ACTIVE OPERATION) ERROR MESSAGE. NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 9800685 ↗
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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