AutoPulse®Resuscitation System 100 (REF 8700-0740-14)Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00849111002530), received between Apr 6, 2020 and Aug 28, 2025 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Visual Prompts will not Clear” (18 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 28, 2025Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING THE SHIFT CHECK, THE AUTOPULSE PLATFORM (SN (B)(6) DISPLAYED FAULT CODE 42 (FORCE OVERLOAD TRIPPED) UPON POWERING UP. REBOOTING THE DEVICE DID NOT SOLVE THE ISSUE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22910722 ↗
• MalfunctionMay 15, 2025Visual Prompts will not Clear; Visual Prompts will not Clear

  THE AUTOPULSE PLATFORM (SN (B)(6)) DISPLAYS USER ADVISORY 07 (DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE) UPON POWERING UP. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22029563 ↗
• MalfunctionJun 21, 2024Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING SHIFT CHECK, THE AUTOPULSE PLATFORM SN (B)(6) DISPLAYED "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR" UPON POWERING UP. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19588984 ↗
• MalfunctionJun 19, 2024Unexpected Shutdown; Unexpected Shutdown

  AS REPORTED, THE AUTOPULSE PLATFORM (SN (B)(6)) SHUTS DOWN SOMETIMES DURING TRANSPORT (CLIMBING, WALKING ON STAIRS, AND UPHILLS). NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19564605 ↗
• MalfunctionDec 21, 2023Visual Prompts will not Clear; Visual Prompts will not Clear

  ON 11/29/2023 DURING DEVICE EVALUATION OF THE AUTOPULSE PLATFORM (SN (B)(6)), THE PLATFORM FAILED FUNCTIONAL TESTING UPON POWERING UP DUE TO USER ADVISORY (UA) 45 (NOT AT "HOME" POSITION AFTER POWER-ON/RESTART). NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18373374 ↗
• MalfunctionJul 17, 2023Visual Prompts will not Clear; Visual Prompts will not Clear

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17337221 ↗
• MalfunctionJan 13, 2023Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING SHIFT CHECK, THE AUTOPULSE PLATFORM (SN (B)(4) DISPLAYED FAULT 16 (TIMEOUT MOVING TO TAKE-UP POSITION) WHEN THE START/CONTINUE BUTTON WAS PRESSED. THE CUSTOMER TRIED TO RESTART THE PLATFORM AND USE A DIFFERENT LIFEBAND, BUT THE ISSUE PERSISTED. THE ORIGINAL LIFEBAND PERFORMED AS INTENDED WHEN TESTED ON A DIFFERENT AUTOPULSE PLATFORM. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16159315 ↗
• MalfunctionJan 13, 2023Visual 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) MESSAGE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16159164 ↗
• MalfunctionJan 13, 2023Visual Prompts will not Clear; Visual Prompts will not Clear

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16158964 ↗
• MalfunctionNov 23, 2021Visual Prompts will not Clear; Visual Prompts will not Clear

  THE CUSTOMER REPORTED THAT DURING SHIFT CHECKS, THE AUTOPULSE PLATFORM (S/N 43161) WOULD STOP COMPRESSIONS INTERMITTENTLY AND DISPLAY USER ADVISORY (UA) 02 (COMPRESSION TRACKING ERROR). NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12866440 ↗
• MalfunctionSep 16, 2021Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING SHIFT CHECK, THE AUTOPULSE PLATFORM (S/N (B)(4)) DISPLAYED "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR" UPON POWERING UP. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12485139 ↗
• MalfunctionSep 26, 2020No Display/Image; Noise, Audible; No Display/Image; Noise, Audible

  DURING THE SHIFT CHECK, UPON POWERING ON OF THE AUTOPULSE PLATFORM (SN (B)(4)), THE CUSTOMER NOTICED THAT THE LCD DISPLAY WAS BLANK, AND THE PLATFORM MADE A LOUD CLICKING SOUND. ALSO, NO RESPONSE FROM ANY BUTTON WAS NOTED. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10591149 ↗
• MalfunctionJul 14, 2020Visual Prompts will not Clear; Visual Prompts will not Clear

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

  Patient problems: No Patient Involvement

  MAUDE report 10273308 ↗
• MalfunctionJul 10, 2020Visual Prompts will not Clear; Visual Prompts will not Clear

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

  Patient problems: No Patient Involvement

  MAUDE report 10258723 ↗
• MalfunctionJul 9, 2020Use of Device Problem; Use of Device Problem

  DURING INSTALLATION, CUSTOMER REPORTED THAT ALL OF THE BUTTONS ON THE AUTOPULSE PLATFORM (SERIAL # (B)(4)) ARE INTERMITTENTLY NOT FUNCTIONING AFTER POWER ON. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10255610 ↗
• MalfunctionJun 17, 2020Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING SHIFT CHECK, THE CUSTOMER REPORTED THAT THE AUTOPULSE PLATFORM (SN (B)(4)) DISPLAYED "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR " UPON POWERING ON. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10161027 ↗
• MalfunctionMay 28, 2020Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING SHIFT CHECK, WHEN THE AUTOPULSE PLATFORM (SN: (B)(4)) WAS POWERED ON, THE PLATFORM DISPLAYED THE PROMPT "PULL UP LIFEBAND AND PRESS RESTART." THE USER RE-ADJUSTED THE LIFEBAND AND RESTARTED THE PLATFORM. WHEN THE AUTOPULSE WAS POWERED ON, THE PLATFORM DISPLAYED UA45 (NOT AT "HOME" POSITION AFTER POWER-ON/RESTART) ERROR MESSAGE. THE USER RE-ADJUSTED THE LIFEBAND AND RESTARTED THE PLATFORM AGAIN. THE AUTOPULSE PERFORMED COMPRESSIONS FOR ABOUT 20 MINUTES, AND THEN, THE PLATFORM STOPPED FUNCTIONING AND DISPLAYED USER ADVISORY (UA) 17 (MAX MOTOR ON TIME EXCEEDED DURING ACTIVE OPERATION) ERROR MESSAGE. AS PER THE USER, THE ERROR MESSAGES WERE OBSERVED INTERMITTENTLY, ABOUT 2 OR 3 TIMES. EVENTUALLY, THE USER REPLACED THE BATTERY, EXCHANGED THE LIFEBAND, AND RESTARTED THE PLATFORM; HOWEVER, THE ISSUE WAS NOT RESOLVED. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10099610 ↗
• MalfunctionMay 8, 2020Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING THE PATIENT USE, THE PLATFORM DISPLAYED USER ADVISORY (UA) 02 (COMPRESSION TRACKING ERROR) ERROR. THE LIFEBAND WAS NOTED TWISTED INTERMITTENTLY DURING THE OPERATION. THE USER REINSTALLED THE LIFEBAND TO MAKE SURE IT IS PROPERLY INSTALLED, HOWEVER, THE ISSUE PERSISTS. THE CREW IMMEDIATELY REVERTED TO MANUAL CPR. NO CONSEQUENCES OR IMPACT TO PATIENT. THE PLATFORM WAS TESTED BACK AT THE STATION AND WAS CONFIRMED TO PERFORM AS INTENDED WITH THE NEW LIFEBAND. PER A REPORTER, THE LIFEBAND WITH THE ISSUE WAS INSTALLED ON THE PLATFORM FOR ABOUT A MONTH. PLEASE SEE THE FOLLOWING RELATED MFR REPORTS: MFR 3010617000-2020-00485 FOR AUTOPULSE LIFEBAND.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10041025 ↗
• MalfunctionMay 7, 2020Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING PATIENT USE, CUSTOMER REPORTED THAT LIFEBAND WAS TWISTED INTERMITTENTLY ON THE AUTOPULSE PLATFORM (SERIAL #(B)(4)) WHILE OPERATING AND IT DISPLAYED ADVISORY (UA) 02 (COMPRESSION TRACKING ERROR) ERROR MESSAGE. PATIENT'S STATUS INFORMATION WAS REQUESTED BUT THE CUSTOMER DID NOT PROVIDE A RESPONSE, THEREFORE PATIENT'S STATUS IS UNKNOWN. THE LIFEBAND ASSOCIATED WITH THIS COMPLAINT IS SUBMITTED UNDER MFR 3010617000-2020-00488.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10037027 ↗
• MalfunctionMay 6, 2020Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING DEVICE MAINTENANCE, THE AUTOPULSE PLATFORM (SN (B)(4)) DISPLAYED FAULT 16 (TIMEOUT MOVING TO TAKE-UP POSITION) ERROR MESSAGE UPON POWER ON AFTER PRESSING THE CONTINUE BUTTON. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10030911 ↗
• MalfunctionApr 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 " UPON POWERING ON. ERROR MESSAGE COULD NOT BE CLEARED BY THE USER. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9931587 ↗

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