AutoPulse®Resuscitation System 100 (REF 8700-0740-22)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00849111001175), received between Nov 11, 2015 and Mar 20, 2020 — 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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 20, 2020Visual Prompts will not Clear; Visual Prompts will not Clear

  CUSTOMER REPORTED THAT THE AUTOPULSE PLATFORM (SERIAL #(B)(4)) DISPLAYED USER ADVISORY - "(UA)18" (MAX TAKE-UP REVOLUTION EXCEEDED) UPON POWERING ON. NO CONSEQUENCES OR IMPACT TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9861607 ↗
• MalfunctionMar 2, 2016No Display/Image; Device Operates Differently Than Expected; No Display/Image; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE AUTOPULSE PLATFORM'S (S/N (B)(4)) DISPLAY WAS NOT SHOWING ANY INFORMATION AND WAS "DARK." THERE WAS NO REPORT OF PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 5474267 ↗
• MalfunctionNov 11, 2015Visual Prompts will not Clear; Device Displays Incorrect Message

  CUSTOMER REPORTED THEIR AUTOPULSE PLATFORM DISPLAYS USER ADVISORY (UA) 16 (TIMEOUT MOVING TO TAKE-UP POSITION) AND METALLIC SOUNDS WERE HEARD WHEN INITIATING THE DEVICE. THE PLATFORM WAS WORKING INTERMITTENTLY. THE CUSTOMER USED KNOWN GOOD BATTERIES AND LIFEBANDS WITH THE DEVICE. NO PATIENT INVOLVEMENT REPORTED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 5218588 ↗

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