AutoPulse®Resuscitation System 100 (REF 8700-0700-11)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00849111000154), received between Apr 8, 2016 and Dec 22, 2025 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Visual Prompts will not Clear” (7 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 22, 2025Visual Prompts will not Clear; Visual Prompts will not Clear

  THE CUSTOMER REPORTED THAT DURING A DEVICE CHECK BY CLINICAL ENGINEERING, THE AUTOPULSE PLATFORM (SN (B)(6) DISPLAYED "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR." NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23873854 ↗
• MalfunctionJul 22, 2025Erratic or Intermittent Display; Display or Visual Feedback Problem; Erratic or Intermittent Display; Display or Visual Feedback Problem

  THE CUSTOMER REPORTED THE HEAD RESTRAINT WIRES ON THE AUTOPULSE PLATFORM (SN (B)(6) ARE BROKEN AND THE DISPLAY OCCASIONALLY FAILS TO TURN ON. THIS WAS NOTICED DURING DEVICE INSPECTION. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22571874 ↗
• MalfunctionSep 17, 2022Failure to Power Up; Failure to Power Up

  AS REPORTED, THE AUTOPULSE PLATFORM SN (B)(4) WAS FOUND TO BE NOT FUNCTIONING. NO ADDITIONAL INFORMATION WAS PROVIDED. IT IS UNKNOWN WHERE THE PROBLEM OCCURRED. HOWEVER, PATIENT USE INFORMATION WAS REQUESTED BUT NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 15443011 ↗
• MalfunctionMay 5, 2021Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING SHIFT CHECK, THE AUTOPULSE PLATFORM (S/N (B)(4)) DISPLAYED A "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR" ERROR MESSAGE UPON POWERING UP. TO TROUBLESHOOT, THE AUTOPULSE WAS RE-STARTED, BUT THE ISSUE WAS NOT RESOLVED. DURING FURTHER TROUBLESHOOTING, THE BATTERY WAS REMOVED AND RE-INSERTED BACK INTO THE PLATFORM, BUT THE ISSUE PERSISTED. LASTLY, THE CUSTOMER FOLLOWED OTHER TROUBLESHOOTING PROCEDURES FROM THE ADMINISTRATIVE MENU WITH NO SUCCESS. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11780760 ↗
• MalfunctionOct 20, 2020Visual Prompts will not Clear; Visual Prompts will not Clear

  AS PART OF ROUTINE SERVICE, THE AUTOPULSE PLATFORM (SN (B)(4) WAS TESTED BY THE CUSTOMER'S BIOMED ENGINEER AND DURING FUNCTIONAL TESTING DISPLAYED AN ERROR MESSAGE "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR" ON THE USER CONTROL PANEL. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10709270 ↗
• MalfunctionOct 16, 2020Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING SHIFT CHECK, THE AUTOPULSE PLATFORM (SN: (B)(4)) DISPLAYED USER ADVISORY (UA) 07 (DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE) ERROR MESSAGE UPON POWERING UP. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10691263 ↗
• MalfunctionJan 13, 2020Unexpected Shutdown; Unexpected Shutdown

  AS REPORTED, THE AUTOPULSE PLATFORM POWERED OFF DURING THE COMPRESSION. THE ISSUE PERSISTS EVEN AFTER THE USER REPLACED THE BATTERIES. NO ADDITIONAL INFORMATION WAS AVAILABLE. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9584455 ↗
• MalfunctionAug 7, 2018Visual Prompts will not Clear; Visual Prompts will not Clear

  AS REPORTED, DURING THE FIRST ACTIVATION OF THE AUTOPULSE PLATFORM (SN (B)(4)), THE DEVICE DISPLAYED USER ADVISORY - UA 12 (LIFEBAND NOT PRESENT). NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7760186 ↗
• MalfunctionJun 6, 2018Device Displays Incorrect Message; Device Operational Issue; Device Displays Incorrect Message; Device Operational Issue

  DURING SHIFT CHECK, THE AUTOPULSE PLATFORM (SN (B)(4)) DISPLAYED A "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR" MESSAGE UPON POWER UP. ADDITIONALLY, THE USER OBSERVED DAMAGED HEAD RESTRAINT BRACKET. NO PATIENT INVOLVEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7575971 ↗
• MalfunctionDec 11, 2017Device Displays Incorrect Message; Device Operational Issue; Device Displays Incorrect Message; Device Operational Issue

  DURING SERVICE ON AN AUTOPULSE PLATFORM (SN: (B)(4)), THE SERVICE TECHNICIAN REPORTED THAT THE AUTOPULSE DISPLAYED A USER ADVISORY (UA) 16 (TIMEOUT MOVING TO TAKE-UP POSITION) AND UA 18 (MAX TAKE-UP REVOLUTION EXCEEDED) ERROR MESSAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7104153 ↗
• MalfunctionSep 29, 2017Device Displays Incorrect Message; Device Operational Issue; Device Displays Incorrect Message; Device Operational Issue

  AS REPORTED, THE AUTOPULSE PLATFORM (SN: (B)(4)) DISPLAYED MULTIPLE USER ADVISORY (UA) MESSAGES OF UA 02 (COMPRESSION TRACKING ERROR), UA 17 (MAX MOTOR ON TIME EXCEEDED DURING ACTIVE OPERATION), AND UA 45 (NOT AT "HOME" POSITION AFTER POWER-ON/RESTART) DURING INITIAL TESTING. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 6904737 ↗
• MalfunctionAug 10, 2017Visual Prompts will not Clear; Device Displays Incorrect Message; Device Operational Issue; Visual Prompts will not Clear; Device Displays Incorrect Message; Device Operational Issue

  IT WAS REPORTED THAT THE AUTOPULSE PLATFORM (SN (B)(4)) DISPLAYED A SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR ERROR MESSAGE. THE ISSUE WAS OBSERVED DURING ROUTINE CHECK, NO PATIENT WAS INVOLVED WITH THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 6785763 ↗
• MalfunctionApr 6, 2017No Display/Image; Device Operates Differently Than Expected; Device Operational Issue; No Display/Image; Device Operates Differently Than Expected; Device Operational Issue

  IT WAS REPORTED THAT THE AUTOPULSE PLATFORM (SN: (B)(4)) DISPLAY IS NOT WORKING. THE DISPLAY DOES NOT STAY POWERED ON, MAKING IT DIFFICULT FOR THE CUSTOMER TO READ THE MESSAGES. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 6464436 ↗
• MalfunctionDec 2, 2016No Display/Image; Device Operates Differently Than Expected; No Display/Image; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE METAL RESTRAINT ON THE UPPER HOUSING BROKE AND THE DISPLAY'S BACKLIGHT DOES NOT WORK. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 6143432 ↗
• MalfunctionApr 8, 2016Visual Prompts will not Clear; Device Displays Incorrect Message; Visual Prompts will not Clear; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING A SHIFT CHECK AND UPON POWERING UP THE DEVICE, THE AUTOPULSE PLATFORM (S/N (B)(4)) DISPLAYED USER ADVISORY (UA) 7 (DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE) ERROR MESSAGE. NO PATIENT INVOLVED WAS REPORTED WITH THIS EVENT. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 5563565 ↗

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