AutoPulse®Resuscitation System 100 (REF 8700-0700-08-66)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00849111000291), received between Apr 27, 2018 and Oct 18, 2018 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Visual Prompts will not Clear” (6 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 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 18, 2018Use of Device Problem; Use of Device Problem

  DURING PATIENT USE ON AN OBESE PATIENT (130-140 KG), THE AUTOPULSE PLATFORM (SN (B)(4)) STOPPED AFTER 3-5 COMPRESSIONS AND DISPLAYED A USER ADVISORY (UA) 17 (MAX MOTOR ON TIME EXCEEDED DURING ACTIVE OPERATION) ON THE USER CONTROL PANEL. THE CREW TRIED TO TROUBLESHOOT THE PLATFORM USING ANOTHER BATTERIES, BUT WAS UNABLE TO CLEAR THE ERROR. THE CREW REVERTED TO MANUAL CPR FOR AN UNKNOWN PERIOD OF TIME. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7981446 ↗
• MalfunctionOct 10, 2018Use of Device Problem; Use of Device Problem

  DURING PATIENT USE, A CUSTOMER REPORTED THAT THE AUTOPULSE PLATFORM STOPPED COMPRESSIONS AND POWER OFF BY ITSELF. PER CUSTOMER, THE PLATFORM STOPS WORKING WITH MULTIPLE KNOWN GOOD BATTERIES. THERE WERE NO ERRORS REPORTED. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7954735 ↗
• MalfunctionSep 21, 2018Visual Prompts will not Clear; Visual Prompts will not Clear

  IT WAS REPORTED THAT DURING PATIENT USE, THE AUTOPULSE PLATFORM (SN (B)(4)) INTERMITTENTLY DISPLAYED ERROR MESSAGE USER ADVISORY (UA) 17 (MAX MOTOR ON TIME EXCEEDED DURING ACTIVE OPERATION). PER REPORTER, THE PLATFORM STOPPED COMPRESSIONS AFTER DISPLAYING USER ADVISORY (UA) 08 (MOTOR CONTROLLER FAULT DETECTED). NO KNOWN PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7898793 ↗
• MalfunctionSep 18, 2018Visual Prompts will not Clear; Visual Prompts will not Clear

  THE AUTOPULSE PLATFORM (SN (B)(4)) DISPLAYED A SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR MESSAGE DURING PATIENT USE. NO KNOWN PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7887958 ↗
• MalfunctionSep 18, 2018Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING SHIFT CHECK, THE AUTOPULSE PLATFORM (SN (B)(4)) DISPLAYED USER ADVISORY (UA) 41(PATIENT TEMPERATURE FAILURE) ERROR MESSAGE. ADDITIONALLY, CUSTOMER REQUESTED PREVENTIVE MAINTENANCE FOR THE PLATFORM. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7887295 ↗
• MalfunctionSep 7, 2018Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING THE CALL, THE AUTOPULSE PLATFORM ((B)(4)) STOPPED COMPRESSIONS AFTER DISPLAYING USER ADVISORY (UA) 02 (COMPRESSION TRACKING ERROR), USER ADVISORY (UA) 08 (MOTOR CONTROLLER FAULT DETECTED) AND USER ADVISORY (UA) 41 (PATIENT TEMPERATURE SENSOR FAILURE) ERROR MESSAGES. THE CREW IMMEDIATELY REVERTED TO MANUAL CPR FOR AN UNKNOWN PERIOD OF TIME UNTIL THE SECOND AUTOPULSE PLATFORM WAS USED TO CONTINUE COMPRESSIONS. NO KNOWN PATIENT CONSEQUENCES WERE REPORTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7856697 ↗
• MalfunctionJun 21, 2018Visual Prompts will not Clear; Device Displays Incorrect Message; Device Operational Issue; Visual Prompts will not Clear; Device Displays Incorrect Message; Device Operational Issue

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

  Patient problems: No Patient Involvement

  MAUDE report 7625387 ↗
• MalfunctionJun 15, 2018Device Operates Differently Than Expected; Device Operational Issue; Device Operates Differently Than Expected; Device Operational Issue

  THE AUTOPULSE PLATFORM ((B)(4)) WAS DEPLOYED WITHOUT ISSUE AND USED ON A PATIENT PERFORMING CONTINUOUS COMPRESSION FOR AN UNSPECIFIED AMOUNT OF TIME, HOWEVER, AFTER SOME TIME THE PLATFORM STOPPED COMPRESSION. ADDITIONALLY, THE PLATFORM'S HEAD RESTRAINT CABLE WAS FOUND DAMAGED. NO PATIENT HARM OR CONSEQUENCE WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7607228 ↗
• MalfunctionJun 7, 2018Visual Prompts will not Clear; Device Displays Incorrect Message; Device Operational Issue; Visual Prompts will not Clear; Device Displays Incorrect Message; Device Operational Issue

  DURING DEVICE CHECK, THE AUTOPULSE PLATFORM (SN (B)(4)) DISPLAYED USER ADVISORY (UA) 02 (COMPRESSION TRACKING ERROR) MESSAGE WHEN TESTED ON THE MANIKIN. NO PATIENT WAS INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 7579988 ↗
• MalfunctionMay 10, 2018No Display/Image; No Display/Image

  DURING A PREVENTIVE MAINTENANCE FOR AUTOPULSE PLATFORM (SN: (B)(4)), THE LCD WAS OBSERVED TO BE FLICKERING.

  Patient problems: No Patient Involvement

  MAUDE report 7505209 ↗
• MalfunctionApr 27, 2018Device Displays Incorrect Message; Device Operational Issue; Device Displays Incorrect Message; Device Operational Issue

  THE AUTOPULSE PLATFORM ((B)(4)) WAS RETURNED FOR PREVENTIVE MAINTENANCE. AS PART OF ROUTINE SERVICE, THE DEVICE WAS TESTED AND DURING INITIAL POWER UP, DISPLAYED USER ADVISORY (UA) 41 (PATIENT TEMPERATURE SENSOR FAILURE) ERROR MESSAGE ON THE USER CONTROL PANEL.

  Patient problems: No Patient Involvement

  MAUDE report 7470974 ↗

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