AutoPulse®Resuscitation System 100 (REF 8700-0700-20)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00849111000178), received between Jul 19, 2017 and Apr 19, 2019 — classified as 1 injury, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A (B)(6) YEARS OLD MALE WENT INTO CARDIAC ARREST DUE TO PULMONARY EMBOLISM. THE MANUAL CPR WAS PERFORMED BY THE RESPONDING AGENCY FOR AN UNKNOWN LENGTH OF TIME PRIOR TO USE OF AUTOPULSE. THE PLATFORM PERFORMED COMPRESSIONS BETWEEN 90 AND 120 MINUTES DURING THE PATIENT TRANSPORT (100 KM) TO THE HOSPITAL. THE ROSC WAS NOT ACHIEVED AND THE PATIENT EXPIRED. THE CT SCAN CONFIRMED THE CAUSE OF THE DEATH WAS A PULMONARY EMBOLISM. DURING THE PATIENT AUTOPSY, THE AORTIC B-DISSECTION WAS DISCOVERED. THE INFORMATION RELATED TO THE PREEXISTING MEDICAL CONDITIONS OF THE PATIENT WAS NOT PROVIDED. ACCORDING TO THE DOCTOR, THE PATIENT DEATH WAS NOT ATTRIBUTED TO THE DEVICE.

  Patient problems: Aortic Dissection

  MAUDE report 8533515 ↗
• MalfunctionJul 19, 2017Device Displays Incorrect Message; Device Operational Issue; Device Displays Incorrect Message; Device Operational Issue

  AS REPORTED DURING PATIENT USE, THE AUTOPULSE PLATFORM (SN: (B)(4)) PERFORMED COMPRESSION FOR APPROXIMATELY 3-4 MINUTES AND THEN DISPLAYED ERROR MESSAGE USER ADVISORY (UA) 08 (MOTOR CONTROLLER FAULT DETECTED) AND 45 (NOT AT "HOME" POSITION AFTER POWER-ON/RESTART). MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE REPORTER FOR ADDITIONAL INFORMATION; HOWEVER, WERE UNSUCCESSFUL. NO FURTHER INFORMATION WAS PROVIDED. NO KNOWN PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6726011 ↗

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