AutoPulse®Resuscitation System 100 (REF 8700-0740-15)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00849111001236), received between May 26, 2017 and Mar 27, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Visual Prompts will not Clear” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 27, 2021Failure to Power Up; Use of Device Problem; Failure to Power Up; Use of Device Problem

  DURING SHIFT CHECK, THE AUTOPULSE PLATFORM (S/N (B)(4)) KEPT REBOOTING AFTER THE GREEN START/CONTINUE BUTTON WAS PRESSED. AS REPORTED, THE BATTERY WAS FULLY CHARGED PRIOR TO INSERTING IT INTO THE AUTOPULSE PLATFORM. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11579838 ↗
• MalfunctionJan 6, 2021Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING SHIFT CHECK, THE LIFEBAND COMPRESSION STOPPED DURING THE END OF FIRST COMPRESSION FOR ANALYZING THE PATIENT'S SIZE. THEN THE AUTOPULSE PLATFORM (SERIAL (B)(4) ) DISPLAYED USER ADVISORY (UA)02 (COMPRESSION TRACKING ERROR) ERROR MESSAGE ON THE SCREEN. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11121908 ↗
• MalfunctionMay 26, 2017Visual Prompts will not Clear; Device Operational Issue; Visual Prompts will not Clear; Device Operational Issue

  IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE, THE AUTOPULSE PLATFORM (SN: (B)(4)) WAS DISPLAYING ERROR MESSAGE USER ADVISORY 02 (COMPRESSION TRACKING ERROR). NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 6595811 ↗

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