AutoPulse®Resuscitation System 100 (REF 8700-0700-24)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00849111000031), received between Nov 15, 2015 and Oct 29, 2022 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Visual Prompts will not Clear” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 29, 2022Use of Device Problem; Use of Device Problem

  THE CUSTOMER REPORTED THAT THE DRIVESHAFT OF THE AUTOPULSE PLATFORM (SN (B)(4) DOES NOT ROTATE. NO FURTHER INFORMATION WAS PROVIDED. IT IS UNKNOWN WHEN THE PROBLEM OCCURRED. HOWEVER, PATIENT USE INFORMATION WAS REQUESTED, BUT NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15696865 ↗
• MalfunctionApr 7, 2022Display Difficult to Read; Display or Visual Feedback Problem; Display Difficult to Read; Display or Visual Feedback Problem

  DURING SHIFT CHECK, THE CUSTOMER REPORTED THE LCD DISPLAY OF THE AUTOPULSE PLATFORM(SN (B)(4)) IS FLASHING AND NOT READABLE. ALSO, THE BRAKE INTERMITTENTLY POWERS ON AND OFF. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14046209 ↗
• MalfunctionApr 1, 2022Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING THE DEVICE CHECK, THE AUTOPULSE PLATFORM (SERIAL #(B)(4) DISPLAYED "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR " UPON POWERING ON. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13982756 ↗
• MalfunctionFeb 20, 2021Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING THE SHIFT CHECK, THE AUTOPULSE PLATFORM (SN (B)(4) ) DISPLAYED FAULT CODE 08 (MOTOR CONTROLLER FAULT DETECTED). NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11355902 ↗
• MalfunctionFeb 17, 2021Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING SHIFT CHECK, THE AUTOPULSE PLATFORM (S/N (B)(4)) DISPLAYED A FAULT CODE 27 (ENCODER FAULT) ERROR MESSAGE. IT WAS ALSO REPORTED THAT THE TOP COVER WAS OBSERVED TO BE CRACKED. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11340844 ↗
• MalfunctionNov 15, 2015Device Inoperable

  IT WAS REPORTED THAT THE MOTOR FOR TWO AUTOPULSE PLATFORMS (S/N'#S) (B)(4) WERE NOT WORKING AND NO COMPRESSIONS WERE ABLE TO BE PERFORMED. THERE WAS NO REPORT OF ANY PATIENT INVOLVEMENT. NO ADDITIONAL DETAILS WERE PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 5223979 ↗

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