AutoPulse®Resuscitation System 100 (REF 8700-0730-08)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00849111000536), received between Mar 7, 2018 and Dec 6, 2024 — classified as 16 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 6, 2024Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING SHIFT CHECK, THE AUTOPULSE PLATFORM (B)(6) DISPLAYED THE FAULT 41 (PATIENT TEMPERATURE SENSOR FAILURE) MESSAGE. PER THE REPORTER, THE DEVICE WAS STORED IN THE AUTOPULSE QUICK CASE WITHIN THE DESIGNATED DRAWER OF THE EMERGENCY MEDICAL VEHICLE. THE FAULT DISPLAYED WHEN THE DEVICE WAS ON THE HARD SURFACE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20860779 ↗
• MalfunctionFeb 1, 2024Use of Device Problem; Use of Device Problem

  DURING SERVICING AT ZOLL, THE AUTOPULSE PLATFORM (SN (B)(6)) FAILED THE LOAD CELL CHARACTERIZATION TEST. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18623882 ↗
• MalfunctionJul 17, 2023Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING SHIFT CHECK, THE AUTOPULSE PLATFORM (SN (B)(6)) DISPLAYED USER ADVISORY "(UA)07" (DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE) MESSAGE UPON POWERING UP. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17334167 ↗
• MalfunctionDec 20, 2021Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING THE PREVENTIVE MAINTENANCE (PM) ON (B)(6) 2021, THE AUTOPULSE PLATFORM (SN (B)(4)) FAILED INITIAL FUNCTIONAL TESTING DUE TO FAULT 29 (LOSS OF BRAKE CONNECTIVITY) AND MULTIPLE FAULT 08 (MOTOR CONTROLLER FAULT DETECTED) CODES. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13041264 ↗
• MalfunctionApr 1, 2021Visual Prompts will not Clear; Visual Prompts will not Clear

  ON (B)(6) 2021, DURING PREVENTIVE MAINTENANCE THE AUTOPULSE PLATFORM (SN (B)(4)) FAILED FUNCTIONAL TESTING AS THE DRIVE TRAIN MOTOR WAS UNABLE TO MAINTAIN COMPRESSIONS AND DISPLAYED "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR" ERROR MESSAGE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11605607 ↗
• MalfunctionJan 26, 2021Unexpected Shutdown; Unexpected Shutdown

  DURING REANIMATION TRAINING ON A MANIKIN, CUSTOMER REPORTED THAT THE AUTOPULSE PLATFORM (SERIAL #(B)(4)) POWER OFF BY ITSELF. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11228303 ↗
• MalfunctionNov 6, 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." NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10799130 ↗
• MalfunctionJul 10, 2020Visual Prompts will not Clear; Visual Prompts will not Clear

  AS REPORTED, THE AUTOPULSE PLATFORM (SN: (B)(4)) DISPLAYED "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR" ERROR MESSAGE. NO FURTHER INFORMATION WAS PROVIDED BY THE CUSTOMER. 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 10256104 ↗
• MalfunctionApr 11, 2019Display Difficult to Read; Display Difficult to Read

  DURING TRAINING, THE USER OBSERVED BROKEN LCD DISPLAY ON THE AUTOPULSE PLATFORM (SN (B)(4)) AND THE DISPLAY WAS NOT READABLE. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8506335 ↗
• MalfunctionAug 5, 2018Visual Prompts will not Clear; Visual Prompts will not Clear

  AS REPORTED, THE PATIENT WAS REANIMATED WITH THE AUTOPULSE PLATFORM (SN UNKNOWN), AFTER AN INTERRUPTION OF THE RESUSCITATION DUE TO A RE-POSITIONING OF THE PATIENT BY DOCTORS AND NURSES, THE AUTOPULSE PLATFORM DISPLAYED USER ADVISORY - UA 12 (LIFEBAND NOT PRESENT) ERROR MESSAGE. THE RESUSCITATION WAS INTERRUPTED BY PRESSING THE RED CANCEL BUTTON. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7749806 ↗
• MalfunctionMar 9, 2018Device Displays Incorrect Message; Device Operational Issue; Device Displays Incorrect Message; Device Operational Issue

  AS REPORTED, THE AUTOPULSE PLATFORM (B)(4) WAS DISPLAYING USER ADVISORY (UA) 02 (COMPRESSION TRACKING ERROR) AND USER ADVISORY (UA) 17 (MAX MOTOR ON TIME EXCEEDED DURING ACTIVE OPERATION) ERROR MESSAGE. NO ADDITIONAL INFORMATION WAS PROVIDED. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 7329448 ↗
• MalfunctionMar 9, 2018Device Displays Incorrect Message; Device Operational Issue; Device Displays Incorrect Message; Device Operational Issue

  DURING PREVENTIVE MAINTENANCE, THE AUTOPULSE PLATFORM (B)(4) WAS DISPLAYING USER ADVISORY (UA) 29 (LOSS OF BRAKE CONNECTIVITY) ERROR MESSAGE.

  Patient problems: No Patient Involvement

  MAUDE report 7329447 ↗
• MalfunctionMar 9, 2018Device Displays Incorrect Message; Device Operational Issue; Device Displays Incorrect Message; Device Operational Issue

  DURING PREVENTIVE MAINTENANCE, THE AUTOPULSE PLATFORM (B)(4) WAS DISPLAYING ERROR MESSAGE "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR". NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 7329446 ↗
• MalfunctionMar 9, 2018Device Displays Incorrect Message; Device Operational Issue; Device Displays Incorrect Message; Device Operational Issue

  DURING PREVENTIVE MAINTENANCE, THE AUTOPULSE PLATFORM (SN (B)(4) WAS DISPLAYING ERROR MESSAGE "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR".

  Patient problems: No Patient Involvement

  MAUDE report 7329445 ↗
• MalfunctionMar 9, 2018Device Operates Differently Than Expected; Device Operational Issue; Device Operates Differently Than Expected; Device Operational Issue

  DURING PREVENTIVE MAINTENANCE, THE AUTOPULSE PLATFORM (SN (B)(4) WAS OBSERVED WITH NO LCD BACKLIGHT AND BROKEN BATTERY BAY.

  Patient problems: No Patient Involvement

  MAUDE report 7329444 ↗
• MalfunctionMar 7, 2018Device Displays Incorrect Message; Device Operational Issue; Device Displays Incorrect Message; Device Operational Issue

  DURING PREVENTIVE MAINTENANCE, THE AUTOPULSE PLATFORM (SN (B)(4)) WAS DISPLAYING ERROR MESSAGE "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR".

  Patient problems: No Patient Involvement

  MAUDE report 7322479 ↗

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