AutoPulse®Resuscitation System 100 (REF 8700-0740-21)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00849111001199), received between Mar 10, 2016 and Nov 9, 2016 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 9, 2016Device Issue; Device Operates Differently Than Expected; Device Issue; Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING TRAINING, THE AUTOPULSE PLATFORM (S/N: (B)(4)) DID NOT FUNCTION PROPERLY. THE NEW LIFEBAND DETACHED FROM THE PLATFORM. MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE REPORTER TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, WERE UNSUCCESSFUL. NO PATIENT INVOLVED WITH THIS EVENT. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6091603 ↗
• MalfunctionMar 10, 2016Visual 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

  IT WAS REPORTED THAT AUTOPULSE PLATFORM (S/N (B)(4)) STOPPED WORKING UNEXPECTEDLY. NO INFORMATION WAS PROVIDED IF A PATIENT WAS INVOLVED WITH THIS EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Information

  MAUDE report 5494000 ↗
• MalfunctionMar 10, 2016Visual 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

  IT WAS REPORTED THAT AUTOPULSE PLATFORM (S/N (B)(4)) STOPPED WORKING UNEXPECTEDLY. NO INFORMATION WAS PROVIDED IF A PATIENT WAS INVOLVED WITH THIS EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Information

  MAUDE report 5493043 ↗
• MalfunctionMar 10, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED TO ZOLL THAT THE AUTOPULSE PLATFORM EXPERIENCED SEVERAL PROBLEMS AND STOPPAGES DURING USE. NO FURTHER INFORMATION PROVIDED AND NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5492525 ↗

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