Skip to content

AutoPulse®Resuscitation System 100 (UDI 00849111001021)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

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00849111001021), received between Jun 15, 2018 and Jul 16, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Device Displays Incorrect Message1
  • Device Operational Issue1
  • Visual Prompts will not Clear1

Patient problems

  • No Known Impact Or Consequence To Patient1
  • No Patient Involvement1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJul 16, 2018Visual Prompts will not Clear; Visual Prompts will not Clear

    DURING BIOMED TESTING, THE AUTOPULSE PLATFORM (SN (B)(4)) DISPLAYED A USER ADVISORY (UA) 12 (LIFEBAND NOT DETECTED) ERROR MESSAGE AFTER COMPRESSION OF MANNEQUIN BETWEEN 1 TO 2 MINUTES. NO PATIENT INVOLVEMENT.

    Patient problems: No Patient Involvement

    MAUDE report 7692638 ↗
  • MalfunctionJun 15, 2018Device Displays Incorrect Message; Device Operational Issue; Device Displays Incorrect Message; Device Operational Issue

    DURING SHIFT CHECK, THE AUTOPULSE PLATFORM (SN (B)(4)) DISPLAYED USER ADVISORY (UA) 7 (DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE) ERROR MESSAGE. NO PATIENT INVOLVEMENT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7605455 ↗

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

Other Compressor, Cardiac, External devices

All Compressor, Cardiac, External devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.