AutoPulse®Resuscitation System 100 (REF 8700-0740-04)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00849111002516), received between Feb 21, 2020 and Dec 13, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Visual Prompts will not Clear” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 13, 2024Visual Prompts will not Clear; Visual Prompts will not Clear

  THE DISTRIBUTOR REPORTED THAT THE AUTOPULSE PLATFORM (SN (B)(6)) DISPLAYED A "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR" MESSAGE UPON POWERING ON. 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

  MAUDE report 20930036 ↗
• MalfunctionDec 9, 2024Visual Prompts will not Clear; Visual Prompts will not Clear

  THE DISTRIBUTOR REPORTED THAT DURING THE DEVICE INSPECTION, THE AUTOPULSE PLATFORM (SN: (B)(6) DISPLAYED USER ADVISORY 07 (DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE) AND UA19 (MAX APPLIED LOAD EXCEEDED) MESSAGES AFTER PERFORMING A FEW COMPRESSIONS. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20880372 ↗
• MalfunctionSep 27, 2021Display Difficult to Read; Display or Visual Feedback Problem; Display Difficult to Read; Display or Visual Feedback Problem

  DURING SHIFT CHECK, THE BACKLIGHT DOES NOT ILLUMINATE ON THE LCD OF THE AUTOPULSE PLATFORM (SN (B)(4)). PER REPORTER, THE DISPLAY IS UNREADABLE WHEN THE BACKLIGHT IS NOT ILLUMINATING. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12533776 ↗
• MalfunctionDec 3, 2020Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING SHIFT CHECK, CUSTOMER REPORTED THAT THE AUTOPULSE PLATFORM (SERIAL #(B)(4)) DISPLAYED "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR " UPON POWERING ON. ERROR MESSAGE COULD NOT BE CLEARED BY THE USER. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10939751 ↗
• MalfunctionMar 11, 2020Visual Prompts will not Clear; Visual Prompts will not Clear

  THE AUTOPULSE PLATFORM (SN (B)(4) DISPLAYED FAULT CODE 16 (TIMEOUT MOVING TO TAKE-UP POSITION) ERROR MESSAGE. THE PLATFORM POWERED OFF AND POWERED ON BY ITSELF . PATIENT USE INFORMATION WAS REQUESTED BUT NO ADDITIONAL INFORMATION WAS PROVIDED, THEREFORE PATIENT USE IS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9821168 ↗
• MalfunctionFeb 21, 2020Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING SHIFT CHECK, WHEN THE AUTOPULSE PLATFORM (SN: (B)(4)) WAS POWERED ON, THE LIFEBAND (LOT # UNKNOWN) DID NOT RETRACT TO START COMPRESSIONS, AND FAULT CODE 16 (TIMEOUT MOVING TO TAKE-UP POSITION) WAS DISPLAYED ON THE PLATFORM. THE USER RE-ADJUSTED THE LIFEBAND AND PRESSED THE RESTART BUTTON TO CLEAR THE FAULT CODE; HOWEVER, THE ISSUE WAS NOT RESOLVED. NO PATIENT INVOLVEMENT. PLEASE SEE THE FOLLOWING RELATED MFR REPORT: MFR # 3010617000-2020-00257 FOR THE LIFEBAND (LOT # UNKNOWN).

  Patient problems: No Patient Involvement

  MAUDE report 9741996 ↗

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