AutoPulse®Resuscitation System 100 (REF 8700-0740-10)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00849111001113), received between Feb 27, 2019 and Mar 16, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Visual Prompts will not Clear” (9 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 16, 2026Visual Prompts will not Clear

  AS REPORTED, THE AUTOPULSE PLATFORM (SN (B)(6)) DISPLAYS A "REPLACE BATTERY" ERROR MESSAGE EVEN WHEN FULLY CHARGED BATTERIES WERE PLACED. 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 24613313 ↗
• MalfunctionAug 21, 2025Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING SHIFT CHECK, THE CUSTOMER NOTICED THAT THE AUTOPULSE PLATFORM (SN (B)(6)) SOMETIMES DISPLAYS "REPLACE BATTERY" ERROR MESSAGE. PER THE CUSTOMER, THE BATTERY WAS FULLY CHARGED AND CALIBRATED. THE CUSTOMER REPLACED THE BATTERY, BUT THE ISSUE PERSISTED. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22868764 ↗
• MalfunctionMar 27, 2025Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING TESTING BY BIOMED, THE AUTOPULSE PLATFORM (SN (B)(6) BEGAN COMPRESSIONS AND STOPPED SHOWING THE USER ADVISORY 17 (MAX MOTOR ON TIME EXCEEDED DURING ACTIVE OPERATION) IN LESS THAN A MINUTE. BIOMED RESTARTED THE PLATFORM, BUT THE UA PERSISTED. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21710313 ↗
• MalfunctionDec 28, 2023Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING SHIFT CHECKS, THE AUTOPULSE PLATFORM (SN (B)(6)) KEEPS DISPLAYING USER ADVISORY (UA) 45 (NOT AT "HOME" POSITION AFTER POWER-ON/RESTART). THE CUSTOMER ATTEMPTED TO CLEAR THE ADVISORY MESSAGE BY RETURNING THE DRIVESHAFT TO "HOME" POSITION, FOLLOWING THE ADMINISTRATIVE MENU MORE THAN ONCE. HOWEVER, THE UA45 APPEARS AGAIN THE DAY AFTER IT IS CLEARED. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18414838 ↗
• MalfunctionAug 17, 2022Use of Device Problem; Use of Device Problem

  DURING PATIENT USE, CUSTOMER REPORTED THAT THE AUTOPULSE PLATFORM (SERIAL # (B)(4) STOPPED COMPRESSION. THE LIFEBAND IS IN GOOD POSITION WHEN USED. PATIENT'S STATUS INFORMATION WAS REQUESTED BUT THE CUSTOMER DID NOT PROVIDE A RESPONSE.

  Patient problems: Insufficient Information

  MAUDE report 15245168 ↗
• MalfunctionMar 7, 2022Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING THE SHIFT CHECK, THE AUTOPULSE PLATFORM (SN (B)(4)) DISPLAYED A "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR" ERROR MESSAGE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13679166 ↗
• MalfunctionJul 22, 2021Visual 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. THE LIFEBAND DOESN'T RETRACT BUT NO ISSUE WITH LIFEBAND BUT WITH THE PLATFORM. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12208457 ↗
• MalfunctionMay 14, 2021Use of Device Problem; Visual Prompts will not Clear; Use of Device Problem; Visual Prompts will not Clear

  DURING SHIFT CHECK, THE AUTOPULSE PLATFORM (S/N (B)(4)) DID NOT RETRACT THE LIFEBAND AND DISPLAYED A FAULT CODE 16 (TIMEOUT MOVING TO TAKE-UP POSITION) ERROR MESSAGE. IT WAS ADDITIONALLY REPORTED THAT THE AUTOPULSE PLATFORM DISPLAYED A USER ADVISORY (UA) 45 (NOT AT "HOME" POSITION AFTER POWER-ON/RESTART) ERROR MESSAGE. TO TROUBLESHOOT, THE LIFEBAND WAS REPLACED, BUT THE ISSUE PERSISTED. AS PER THE CUSTOMER, THE AUTOPULSE PLATFORM IS STORED INSIDE THEIR HELICOPTER. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11825182 ↗
• MalfunctionJan 17, 2021Visual Prompts will not Clear; Visual Prompts will not Clear

  THE AUTOPULSE PLATFORM (SN( B)(4) ) DISPLAYED USER ADVISORY (UA) 07 (DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE) ERROR MESSAGE. THE USER TRIED TO TROUBLESHOOT BY RESTARTING THE AUTOPULSE PLATFORM, HOWEVER THE PLATFORM DID NOT RETRACT THE LIFEBAND AND DISPLAYED UA 7. PATIENT USE INFORMATION WAS REQUESTED BUT NO ADDITIONAL INFORMATION WAS PROVIDED, THEREFORE PATIENT USE IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 11183401 ↗
• MalfunctionFeb 27, 2019Visual Prompts will not Clear; Visual Prompts will not Clear

  AS REPORTED, DURING SHIFT CHECK, THE AUTOPULSE PLATFORM (SN (B)(4) DISPLAYED UA16 (TIMEOUT MOVING TO TAKE-UP POSITION) ERROR MESSAGE AND THE USER WAS UNABLE TO CLEAR THE ERROR MESSAGE. NO PATIENT INVOLVEMENT.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 8374947 ↗

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