AutoPulse®Resuscitation System 100 (UDI 00849111001564)Recalls & reported problems
Zoll Circulation, Inc. · The AutoPulse Resuscitation System Model 100 is an automated, portable, battery powered device that compresses the chest of an adult human as an adjunct to manual CPR. · Class 2
All models of AutoPulseResuscitation System (46)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00849111001564), received between Dec 29, 2023 and Dec 29, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Visual Prompts will not Clear” (1 report).
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 Clear1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 29, 2023Visual Prompts will not Clear; Visual Prompts will not Clear
DURING THE DEVICE CHECK BY BIOMED, THE AUTOPULSE PLATFORM SN (B)(6) DISPLAYED A "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR" MESSAGE UPON POWERING ON. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18416807 ↗
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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