AutoPulse®Resuscitation System 100 (REF 8700-0700-08)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 Zoll AutoPulse resuscitation system, a device that delivers automated chest compressions during cardiac arrest, has 114 adverse event reports on file. Many describe visual prompts that will not clear, and some describe the platform failing functional tests or not returning to its start position during maintenance. The reports include 1 death and no injuries, and 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: 110
Deaths reported: 1
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 110 adverse event reports that list this exact device (DI 00849111000130), received between Feb 11, 2016 and Sep 25, 2026 — classified as 1 death, 109 malfunctions.

The most frequently reported specific device problem is “Visual Prompts will not Clear” (65 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

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Visual Prompts will not Clear65
Use of Device Problem18
Device Operational Issue17
Device Displays Incorrect Message15
Output Problem7
Device Operates Differently Than Expected5
Erratic or Intermittent Display3
Display Difficult to Read2

Patient problems

No Clinical Signs, Symptoms or Conditions42
No Patient Involvement30
No Known Impact Or Consequence To Patient13
Insufficient Information12
No Consequences Or Impact To Patient11
Burn(s)1
Laceration(s)1
No Information1

Recent adverse event reports

The 25 most recent of 110 reports, in the reporter's own words as published by the FDA.

MalfunctionSep 25, 2026Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50903840 ↗
MalfunctionMar 11, 2026Visual Prompts will not Clear
DURING PREVENTATIVE MAINTENANCE, THE 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 24571760 ↗
MalfunctionJan 27, 2026Visual Prompts will not Clear
DURING PREVENTATIVE MAINTENANCE, THE AUTOPULSE PLATFORM SN (B)(6) FAILED FUNCTIONAL TESTING DUE TO INTERMITTENT USER ADVISORY 45 (NOT AT "HOME" POSITION AFTER POWER-ON/RESTART) ERROR MESSAGE. THE DRIVESHAFT COULD NOT BE ADJUSTED TO ITS "HOME" POSITION TO CLEAR THE UA45 ADVISORY. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24196353 ↗
MalfunctionJan 19, 2026Use of Device Problem
DURING PREVENTATIVE MAINTENANCE, IT WAS DETERMINED THAT THE AUTOPULSE PLATFORM (SN 20185) DRIVE SHAFT HOME POSITION COULD NOT BE ADJUSTED DUE TO A DEFECTIVE ENCODER. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24111889 ↗
MalfunctionNov 13, 2025Visual Prompts will not Clear; Visual Prompts will not Clear
THE CUSTOMER REPORTED THAT THE AUTOPULSE PLATFORM (SN (B)(6) DISPLAYED A "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR" MESSAGE. THE CUSTOMER HAS NOT PROVIDED ANY ADDITIONAL INFORMATION ABOUT THE CAUSE OR THE TIME OF THE EVENT. 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 23549254 ↗
MalfunctionSep 10, 2025Use of Device Problem; Visual Prompts will not Clear; Use of Device Problem; Visual Prompts will not Clear
DURING PREVENTATIVE MAINTENANCE, THE AUTOPULSE PLATFORM (SN (B)(6) FAILED THE LOAD CELL CHARACTERIZATION CHECK. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23021464 ↗
MalfunctionJul 22, 2025Output Problem; Output Problem
DURING PREVENTATIVE MAINTENANCE ON 7/3/2025 AT ZOLL GERMANY SERVICE DEPOT, THE AUTOPULSE PLATFORM FAILED LOAD CELL CHARACTERIZATION TEST DURING FUNCTIONAL TESTING. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22569822 ↗
MalfunctionJun 5, 2025Visual 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 22154352 ↗
MalfunctionMay 29, 2025Use of Device Problem; Use of Device Problem
DURING THE FUNCTIONAL TESTING OF THE AUTOPULSE PLATFORM (SN (B)(6)) AS PART OF THE SERVICE AT ZOLL, THE BRAKE FAILED TO FUNCTION. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22106670 ↗
MalfunctionMay 22, 2025Visual Prompts will not Clear; Mechanical Jam; Visual Prompts will not Clear; Mechanical Jam
DURING THE SHIFT CHECK, THE AUTOPULSE PLATFORM (SN (B)(6) DISPLAYED FAULT CODE 34 (ENCODER FAILURE), AND THE DRIVE SHAFT COULD NOT BE ROTATED TO THE HOME POSITION. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22067674 ↗
MalfunctionMay 2, 2025Use of Device Problem; Use of Device Problem
DURING PREVENTATIVE MAINTENANCE (PM) PERFORMED AT ZOLL ON (B)(6) 2025, 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 21955817 ↗
MalfunctionFeb 26, 2025Use of Device Problem; Use of Device Problem
DURING PREVENTATIVE MAINTENANCE, THE AUTOPULSE PLATFORM (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 21473014 ↗
MalfunctionJan 28, 2025Visual Prompts will not Clear; Output Problem; Visual Prompts will not Clear; Output Problem
DURING PREVENTATIVE MAINTENANCE, 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 21260751 ↗
MalfunctionDec 6, 2024Visual Prompts will not Clear; Visual Prompts will not Clear
DURING THE DEVICE CHECK, THE AUTOPULSE PLATFORM (SN (B)(6)) DISPLAYED A USER ADVISORY 02 (COMPRESSION TRACKING ERROR). NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20872177 ↗
MalfunctionOct 25, 2024Visual Prompts will not Clear; Visual Prompts will not Clear
DURING PREVENTATIVE MAINTENANCE (PM) AT ZOLL ON 10/21/2024, THE AUTOPULSE PLATFORM (SN (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 20537619 ↗
MalfunctionOct 9, 2024Visual 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 "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR" MESSAGE. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20410038 ↗
MalfunctionOct 8, 2024Visual Prompts will not Clear; Visual Prompts will not Clear
DURING PREVENTATIVE MAINTENANCE (PM) AT ZOLL ON (B)(6) 2024, THE AUTOPULSE PLATFORM (SN (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 20403316 ↗
MalfunctionSep 18, 2024Output Problem; Output Problem
DURING PREVENTATIVE MAINTENANCE, THE AUTOPULSE PLATFORM (B)(6) FAILED THE LOAD CELL CHARACTERIZATION TEST. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20251462 ↗
MalfunctionJun 6, 2024Output Problem; Output Problem
DURING PREVENTATIVE MAINTENANCE (PM) PERFORMED AT ZOLL ON MAY 28, 2024, THE AUTOPULSE PLATFORM SN (B)(6) FAILED THE LOAD CELL CHARACTERIZATION TEST WHILE SERVICING AT ZOLL. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19480298 ↗
MalfunctionJun 6, 2024Output Problem; Output 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 19477575 ↗
MalfunctionFeb 16, 2024Output Problem; Output Problem
THE AUTOPULSE PLATFORM (SN)(B)(6) FAILED THE LOAD CELL CHARACTERIZATION TEST WHILE SERVICING AT ZOLL. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18721728 ↗
MalfunctionNov 22, 2023Visual Prompts will not Clear; Visual Prompts will not Clear
DURING SERVICING AT ZOLL, THE AUTOPULSE PLATFORM SN (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 18193359 ↗
MalfunctionOct 26, 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 A USER ADVISORY (UA) 28 (LOSS OF CLUTCH CONNECTIVITY) MESSAGE. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18012049 ↗
MalfunctionJun 16, 2023Visual Prompts will not Clear; Visual Prompts will not Clear
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 17148582 ↗
MalfunctionMay 10, 2023Use of Device Problem; Visual Prompts will not Clear; Use of Device Problem; Visual Prompts will not Clear
THE CUSTOMER REPORTED THAT THE AUTOPULSE PLATFORM (SN 31888) REPEATEDLY STOPS COMPRESSION DURING THE RESUSCITATION AND DISPLAYS MULTIPLE USER ADVISORIES/FAULTS. TO TROUBLESHOOT THE ERRORS, THE CUSTOMER RESTARTED THE AUTOPULSE PLATFORM SEVERAL TIMES; HOWEVER, WAS UNSUCCESSFUL. MANUAL CPR WAS PERFORMED TO CONTINUE THE RESUSCITATION. NO CONSEQUENCES OR IMPACTS ON THE PATIENT. AFTER THE RESUSCITATION ATTEMPT, THE MEDICAL TECHNICIAN AT THE CLINIC TESTED THE AUTOPULSE PLATFORM AND COULD NOT REPRODUCE THE USER ADVISORIES/FAULTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16908758 ↗

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

Device details

UDI-DI	`00849111000130`
Brand	AutoPulse®Resuscitation System
Model	100
Catalog no.	8700-0700-08
Company	Zoll Circulation, Inc.
Product code	DRM · Compressor, Cardiac, External
Class	Class 2
FDA submission	K112998
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jul 6, 2018

Device type (GMDN): Cardiac resuscitator, line-powered

A mains electricity (AC-powered), external device designed for the application of rhythmic compression to the chest in the region of the heart to provide blood flow during treatment of cardiac arrest [cardiopulmonary resuscitation (CPR)]. The device may consist of a solid base with an attached band that straps across the patient's chest to produce the compressions, or have other configurations. The device is typically used as an adjunct to or substitute for manual external cardiac compression, to prevent fatigue and to provide better consistency in the applied force and rate of compression.

Other Compressor, Cardiac, External devices

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All Compressor, Cardiac, External devices →

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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