AutoPulse®Resuscitation System 100 (REF 8700-0740-16)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 18, 2026 from official FDA records · Editorial policy
Quick summary
This AutoPulse Resuscitation System is an external cardiac compressor with a platform, LifeBand, battery and charger. Its 97 adverse reports describe malfunctions, mostly display and visual prompt messages, operational issues, and component failures such as the motor brake out of specification and LifeBand not functioning; no deaths or injuries are reported. 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
- 97
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 97 adverse event reports that list this exact device (DI 00849111001076), received between Aug 16, 2016 and Nov 18, 2025 — classified as 97 malfunctions.
The most frequently reported specific device problem is “Visual Prompts will not Clear” (74 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Visual Prompts will not Clear74
- Use of Device Problem15
- Device Displays Incorrect Message7
- Display or Visual Feedback Problem7
- Device Operational Issue6
- Display Difficult to Read6
- Failure to Power Up3
- Device Operates Differently Than Expected2
Patient problems
- No Clinical Signs, Symptoms or Conditions58
- No Patient Involvement16
- Insufficient Information15
- No Consequences Or Impact To Patient5
- No Known Impact Or Consequence To Patient4
Recent adverse event reports
The 25 most recent of 97 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 18, 2025Use of Device Problem; Use of Device Problem
DURING PREVENTATIVE MAINTENANCE, THE AUTOPULSE PLATFORM (SN (B)(6) FAILED FUNCTIONAL TESTING AS THE DRIVETRAIN MOTOR BRAKE ASSEMBLY AIR GAP WAS OUT OF SPECIFICATION AND COULD NOT BE ADJUSTED. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23579006 ↗MalfunctionSep 11, 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 23034176 ↗MalfunctionJan 21, 2025Visual Prompts will not Clear; Visual Prompts will not Clear
DURING PREVENTATIVE MAINTENANCE (PM) PERFORMED AT ZOLL, THE AUTOPULSE PLATFORM (SN (B)(6) FAILED DURING FUNCTIONAL TESTING DUE TO THE DISPLAYED USER ADVISORY (UA) 41 (PATIENT TEMPERATURE SENSOR FAILURE) ERROR MESSAGE. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21200184 ↗MalfunctionJan 11, 2025Visual Prompts will not Clear; Visual Prompts will not Clear
AS REPORTED, THE AUTOPULSE PLATFORM (SN (B)(6)) DISPLAYED A FAULT 41 (PATIENT TEMPERATURE SENSOR FAILURE) 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 21132725 ↗MalfunctionOct 28, 2024Visual Prompts will not Clear; Visual Prompts will not Clear
THE CUSTOMER REPORTED THAT THE AUTOPULSE PLATFORM (B)(6) INDICATED THAT THE "LIFEBAND WAS NOT FUNCTIONING PROPERLY". THE RESPONDING STAFF MEMBER DOES NOT RECALL THE EXACT ERROR CODE BUT REMEMBERS THAT THE PLATFORM DISPLAYED A LIFEBAND ERROR. IT IS PRESUMED THIS ISSUE OCCURRED DURING ONE OF THE ASSISTANCE SESSIONS. NO FURTHER INFORMATION WAS PROVIDED. IT IS UNKNOWN WHEN THE PROBLEM OCCURRED. THE PATIENT'S STATUS INFORMATION WAS REQUESTED, BUT THE CUSTOMER DID NOT PROVIDE A RESPONSE.
Patient problems: Insufficient Information
MAUDE report 20550901 ↗MalfunctionOct 8, 2024Visual Prompts will not Clear; Visual Prompts will not Clear
DURING PREVENTATIVE MAINTENANCE (PM), THE AUTOPULSE PLATFORM (B)(6) FAILED FUNCTIONAL TESTING WITH FAULT CODE 16 (TIMEOUT MOVING TO TAKE-UP POSITION). NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20404140 ↗MalfunctionSep 13, 2024Failure to Power Up; Failure to Power Up
THE CUSTOMER REPORTED THE AUTOPULSE PLATFORM (B)(6) NO LONGER TURNS ON. THE AUTOPULSE LI-ION BATTERY WAS CHANGED BUT THE ISSUE STILL PERSISTS. 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 20218301 ↗MalfunctionJul 23, 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". 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 19811819 ↗MalfunctionJun 21, 2024Visual Prompts will not Clear; Visual Prompts will not Clear
DURING PREVENTATIVE MAINTENANCE (PM) PERFORMED AT ZOLL ON JUNE 3, 2024, THE AUTOPULSE PLATFORM (SN (B)(6) FAILED FUNCTIONAL TESTING WITH USER ADVISORY (UA) 07 (DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE). NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19590351 ↗MalfunctionJun 12, 2024Visual Prompts will not Clear; Visual Prompts will not Clear
DURING THE SHIFT CHECK, THE AUTOPULSE PLATFORM (SN (B)(6)) DISPLAYS A FAULT 41 (PATIENT TEMPERATURE SENSOR FAILURE) MESSAGE. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19525271 ↗MalfunctionJun 8, 2024Use of Device Problem; Use of Device Problem
BASED ON THE 4 H'S AND 4 T'S IN THE ALS PROTOCOL, THE SITE ARRIVED AT A POSSIBLE EMBOLISM. FOR THIS, THE PATIENT WAS ADMINISTERED ACTILYSE AND THEN, THE CUSTOMER STARTED MECHANICAL CHEST COMPRESSIONS USING AUTOPULSE PLATFORM (B)(6). ABOUT 15 SECONDS AFTER ACTILYSE WAS STARTED, THE PLATFORM STOPPED COMPRESSIONS WITHOUT INTERVENTION OF A NURSE. DUE TO THIS ISSUE, THE CUSTOMER SWITCHED TO MANUAL COMPRESSIONS AND RESTARTED THE AUTOPULSE PLATFORM. THIS OCCURRED FOR 5 TO 6 BLOCKS AFTER EACH RHYTHM CHECK. THIS AFFECTED THE CONTINUITY OF COMPRESSIONS (SWITCHING BETWEEN MANUAL AND MECHANICAL CPR). FINALLY, THE CUSTOMER SWITCHED TO MANUAL COMPRESSIONS AND USE OF THE PLATFORM WAS DISCONTINUED. THE AUTOPULSE SHOWED NO OBVIOUS ERROR MESSAGE. IN BOTH THE CONTINUOUS COMPRESSION MODE AND THE 30:2 MODE, THE PLATFORM STOPS AFTER 15 SECONDS. PATIENT'S STATUS INFORMATION WAS REQUESTED BUT THE CUSTOMER DID NOT PROVIDE A RESPONSE.
Patient problems: Insufficient Information
MAUDE report 19494109 ↗MalfunctionJun 8, 2024Visual Prompts will not Clear; Visual Prompts will not Clear
DURING PREVENTATIVE MAINTENANCE, THE AUTOPULSE PLATFORM (SN (B)(6)) FAILED FUNCTIONAL TESTING DUE TO FAULT 21 (POSITION CHANGE DOES NOT COINCIDE WITH MOTOR DIRECTION) DISPLAYED UPON POWERING ON. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19493105 ↗MalfunctionMay 1, 2024Display Difficult to Read; Display or Visual Feedback Problem; Use of Device Problem; Display Difficult to Read; Display or Visual Feedback Problem; Use of Device Problem
DURING PREVENTATIVE MAINTENANCE (PM) PERFORMED ON APRIL 08, 2024, THE AUTOPULSE PLATFORM (SN (B)(6) FAILED THE LOAD CELL CHARACTERIZATION TEST AND THE BACKLIGHT OF THE PLATFORM'S LCD FLICKERED BRIEFLY UPON POWERING ON AND WENT DARK AFTERWARD. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19226846 ↗MalfunctionApr 26, 2024Visual Prompts will not Clear; Visual Prompts will not Clear
AS REPORTED, THE AUTOPULSE PLATFORM (B)(6) DISPLAYED FAULT CODE 16 (TIMEOUT MOVING TO TAKE-UP POSITION) 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 19198689 ↗MalfunctionApr 26, 2024Visual Prompts will not Clear; Visual Prompts will not Clear
DURING THE SHIFT CHECK, THE AUTOPULSE PLATFORM SN (B)(6) DISPLAYED A USER ADVISORY (UA) 18 (MAX TAKE-UP REVOLUTIONS EXCEEDED) MESSAGE. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19198687 ↗MalfunctionMar 25, 2024Use of Device Problem; Use of Device Problem
DURING PREVENTATIVE MAINTENANCE (PM), 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 18976314 ↗MalfunctionMar 15, 2024Visual Prompts will not Clear; Visual Prompts will not Clear
DURING PREVENTATIVE MAINTENANCE (PM), THE AUTOPULSE PLATFORM (B)(6) FAILED FUNCTIONAL TESTING AND DISPLAYED USER ADVISORY (UA) 07 (DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE). NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18918565 ↗MalfunctionFeb 29, 2024Visual Prompts will not Clear; Visual Prompts will not Clear
DURING SERVICING AT ZOLL, THE AUTOPULSE PLATFORM (B)(6) FAILED INITIAL FUNCTIONAL TESTING DUE TO FAULT 27 (ENCODER FAULT). NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18813467 ↗MalfunctionFeb 14, 2024Visual Prompts will not Clear; Visual Prompts will not Clear
DURING PREVENTATIVE MAINTENANCE (PM) ON (B)(6) 2024, THE AUTOPULSE PLATFORM SN (B)(6) DISPLAYED FAULT CODE 16 (TIMEOUT MOVING TO TAKE-UP POSITION) DURING THE FUNCTIONAL RUN-IN TEST. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18701018 ↗MalfunctionJan 24, 2024Visual Prompts will not Clear; Visual Prompts will not Clear
DURING PREVENTATIVE MAINTENANCE (PM), THE AUTOPULSE PLATFORM (SN 41436) FAILED FUNCTIONAL TESTING AND DISPLAYED FAULT CODE 21 (DRIVE SHAFT TURNS IN WRONG DIRECTION) UPON POWERING UP. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18576515 ↗MalfunctionDec 8, 2023Use of Device Problem; Use of Device Problem
DURING PREVENTATIVE MAINTENANCE (PM), 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 18297750 ↗MalfunctionNov 15, 2023Visual Prompts will not Clear; Visual Prompts will not Clear
DURING SERVICE AT ZOLL, THE AUTOPULSE PLATFORM (SN (B)(6)) FAILED FUNCTIONAL TESTING DUE TO FAULT 43 (FAN FAULT DETECTED) DISPLAYED UPON THE TEST RUN. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18141099 ↗MalfunctionOct 25, 2023Visual Prompts will not Clear; Visual Prompts will not Clear
DURING THE PREVENTATIVE MAINTENANCE (PM) ON (B)(6) 2023, THE RETURNED AUTOPULSE PLATFORM SN (B)(6) FAILED FUNCTIONAL TESTING DUE TO THE "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR" MESSAGE DISPLAYED UPON POWERING UP. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18000910 ↗MalfunctionOct 20, 2023Display or Visual Feedback Problem; Visual Prompts will not Clear; Display or Visual Feedback Problem; Visual Prompts will not Clear
DURING SERVICE AT ZOLL, THE AUTOPULSE PLATFORM (SN 41416) FAILED FUNCTIONAL TESTING DUE TO A "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR" MESSAGE DISPLAYED UPON POWERING ON. ALSO, THE BACKLIGHT OF THE LCD WAS NOTED TO BE FLICKERING BRIEFLY UPON POWERING ON AND WENT DARK AFTERWARD. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17977241 ↗MalfunctionOct 9, 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 17896022 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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