AutoPulse®Resuscitation System 100 (REF 8700-0780-16)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00849111001533), received between Feb 15, 2019 and Feb 15, 2019 — 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.

• MalfunctionFeb 15, 2019Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING SHIFT CHECK, CUSTOMER REPORTED THAT THE AUTOPULSE PLATFORM (SERIAL # (B)(4)) DISPLAYED A USER ADVISORY - UA07 (DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE) ERROR MESSAGE. THE ERROR MESSAGE COULD NOT BE CLEARED BY THE USER. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8345346 ↗

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