AutoPulse®Resuscitation System 100 (REF 8700-0730-20)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00849111000635), received between Oct 25, 2017 and Oct 25, 2017 — classified as 1 malfunction.

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

Recent adverse event reports

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

• MalfunctionOct 25, 2017Visual Prompts will not Clear; Device Displays Incorrect Message; Device Operates Differently Than Expected; Visual Prompts will not Clear; Device Displays Incorrect Message; Device Operates Differently Than Expected

  AS REPORTED DURING SHIFT CHECK, THE AUTOPULSE PLATFORM (SN: (B)(4)) WAS DISPLAYING ERROR MESSAGE USER ADVISORY (UA) 16 (TIMEOUT MOVING TO TAKE-UP POSITION), UA 24 (TIMEOUT MOVING TO "HOME" POSITION) AND "CHECK PATIENT POSITIONING/ALIGNMENT". A FULLY CHARGED LI-ION BATTERY WAS USED DURING THIS EVENT, THE LIFEBAND HAS BEEN CHANGED AND THE CUSTOMER TRIED TO RESTART THE PLATFORM; HOWEVER, THE ERROR MESSAGES PERSISTED. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 6978615 ↗

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