AutoPulse®Resuscitation System 100 (REF 8700-0700-27)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00849111000055), received between May 27, 2025 and May 27, 2025 — 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2025Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING THE SHIFT CHECK, THE AUTOPULSE PLATFORM (SN (B)(6)) DISPLAYED "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR" WHEN POWERED ON. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22089632 ↗

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