AutoPulse®Resuscitation System 100 (REF 8700-0700-10)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00849111000239), received between Oct 8, 2015 and May 31, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Operational Issue” (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.

• MalfunctionMay 31, 2018Device Operates Differently Than Expected; Device Operational Issue; Device Operates Differently Than Expected; Device Operational Issue

  AS REPORTED, THE AUTOPULSE PLATFORM (SN (B)(4)) INTERMITTENTLY POWERED OFF DURING SHIFT CHECK. IN ADDITION, THE USER OBSERVED DAMAGED TOP COVER ON THE PLATFORM. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7559167 ↗
• MalfunctionMay 22, 2018Device Displays Incorrect Message; Device Operational Issue; Device Displays Incorrect Message; Device Operational Issue

  THE AUTOPULSE PLATFORM ((B)(4)) DISPLAYED A "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR" MESSAGE. THE REPORTER WAS UNABLE TO SPECIFY IF THE ISSUE OCCURRED DURING SHIFT CHECK OR PATIENT USE. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7535548 ↗
• MalfunctionOct 8, 2015Device Stops Intermittently

  IT WAS REPORTED THAT WHILE TESTING THE AUTOPULSE ON A MANNEQUIN THE AUTOPULSE WOULD COMPLETE 2-3 COMPRESSIONS THEN POWER DOWN. THE BATTERY WAS FULLY CHARGED. THE CUSTOMER REPORTED THAT THIS DID NOT OCCUR WHILE USING IT WITH A PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 5135353 ↗

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