AutoPulse®Resuscitation System 100 (REF 8700-0730-11)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00849111000598), received between Feb 13, 2017 and Feb 24, 2026 — classified as 14 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 24, 2026Use of Device Problem

  THE CUSTOMER REPORTED THAT THE AUTOPULSE PLATFORM (SN (B)(6)) DOES NOT RECOGNIZE THE LIFEBAND. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS WAS NOTICED DURING A MAINTENANCE CHECK. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24436054 ↗
• MalfunctionJan 8, 2025Visual Prompts will not Clear; Visual Prompts will not Clear

  THE CUSTOMER REPORTED DURING PATIENT USE THE AUTOPULSE PLATFORM (SN (B)(6) DISPLAYED A USER ADVISORY (UA) 07 (DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE) MESSAGE. THE OPERATOR TRIED TO RE-ALIGN THE LIFEBAND BUT THE ERROR DID NOT CLEAR. NO FURTHER INFORMATION WAS PROVIDED. PATIENT'S STATUS INFORMATION WAS REQUESTED BUT THE CUSTOMER DID NOT PROVIDE A RESPONSE.

  Patient problems: Insufficient Information

  MAUDE report 21105757 ↗
• MalfunctionJul 3, 2024Visual 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) UPON POWERING UP. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19668632 ↗
• MalfunctionFeb 9, 2024Use of Device Problem; Use of Device Problem

  DURING SHIFT CHECK, THE CUSTOMER NOTICED THAT THE AUTOPULSE PLATFORM (SN 31271) EMITTED A BURNING SMELL UPON POWERING UP. THE PLATFORM FUNCTIONS AS INTENDED, ASIDE FROM THE BURNING SMELL. THE CUSTOMER COULD NOT LOCATE WHERE THE BURNING SMELL WAS COMING FROM. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18681487 ↗
• MalfunctionAug 25, 2023Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING PATIENT USE, CUSTOMER REPORTED THAT THE AUTOPULSE PLATFORM (SERIAL #31331) DISPLAYED USER ADVISORY "(UA) 45" (DRIVESHAFT NOT AT "HOME" POSITION AFTER POWER-ON/RESTART) ERROR MESSAGE. PATIENT'S STATUS INFORMATION WAS REQUESTED BUT THE CUSTOMER DID NOT PROVIDE A RESPONSE.

  Patient problems: Insufficient Information

  MAUDE report 17621159 ↗
• MalfunctionDec 27, 2022Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING SHIFT CHECK, THE CUSTOMER REPORTED THE AUTOPULSE PLATFORM (SN (B)(4) DISPLAYED USER ADVISORY (UA) 17 (MAX MOTOR ON-TIME EXCEEDED DURING ACTIVE OPERATION) ERROR MESSAGE. THE CUSTOMER TRIED TO REPLACE THE AUTOPULSE LI-ION BATTERY BUT THE ERROR MESSAGE PERSISTED. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16057050 ↗
• MalfunctionOct 28, 2022Visual 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) UPON POWERING ON WHEN THERE IS NO WEIGHT ON THE PLATFORM. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15692627 ↗
• MalfunctionOct 5, 2022Failure to Power Up; Failure to Power Up

  THE CUSTOMER REPORTED THAT DURING THE SHIFT CHECK, THE AUTOPULSE PLATFORM (B)(4) DID NOT POWER UP USING THE FULLY CHARGED AUTOPULSE LI-ION BATTERIES (B)(4) AND (B)(4). THE CUSTOMER STATED THAT THE BATTERY WAS FULLY CHARGED BEFORE USING IT WITH THE AUTOPULSE PLATFORM, AND THE CUSTOMER COULD NOT PROVIDE INFORMATION ON THE STATUS LEDS. THE CUSTOMER STATED THAT THEY DID NOT HAVE ANOTHER LI-ION BATTERY TO TEST THE AUTOPULSE PLATFORM. IN ADDITION, THE CUSTOMER REPORTED A BROKEN HEAD RESTRAINT ON THE AUTOPULSE PLATFORM. NO PATIENT INVOLVEMENT. PLEASE SEE THE FOLLOWING RELATED MFR REPORT: MFR 3010617000-2022-01755 FOR THE AUTOPULSE LI-ION BATTERY (B)(4). MFR 3010617000-2022-01856 FOR THE AUTOPULSE LI-ION BATTERY (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15545729 ↗
• MalfunctionOct 2, 2022Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING THE SHIFT CHECK, THE AUTOPULSE PLATFORM (SN (B)(4) DISPLAYED USER ADVISORY (UA) 20 (POSITION OUT OF RANGE) ERROR MESSAGE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15526334 ↗
• MalfunctionFeb 16, 2021Use of Device Problem; Use of Device Problem

  DURING DEVICE EVALUATION OF THE AUTOPULSE PLATFORM (SN: (B)(4)), THE PLATFORM FAILED THE LOAD CELL CHARACTERIZATION CHECK DURING FUNCTIONAL TESTING. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11335614 ↗
• MalfunctionDec 5, 2020Use of Device Problem; Use of Device Problem

  ON (B)(6) 2020, DURING DEVICE EVALUATION, THE AUTOPULSE PLATFORM (SN (B)(4)) FAILED THE LOAD CELL CHARACTERIZATION CHECK DURING FUNCTIONAL TESTING. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10955601 ↗
• MalfunctionJul 10, 2020Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING THE SHIFT CHECK, THE AUTOPULSE PLATFORM (SN (B)(4)) DISPLAYED USER ADVISORY (UA) 17 (MOTOR ON FOR TOO LONG DURING ACTIVE OPERATION) AND USER ADVISORY (UA) 18 (MAX TAKE-UP REVOLUTION EXCEEDED) ERROR MESSAGES ON THE USER CONTROL PANEL. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10261664 ↗
• MalfunctionApr 1, 2020Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING SHIFT CHECK, CUSTOMER REPORTED THAT THE AUTOPULSE PLATFORM (SERIAL #(B)(4)) DISPLAYED A USER ADVISORY - "(UA) 41" (PATIENT TEMPERATURE SENSOR FAILURE) ERROR MESSAGE AND CRACKED BLACK COVER. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9914435 ↗
• MalfunctionFeb 13, 2017Visual Prompts will not Clear; Device Operates Differently Than Expected; Device Operational Issue; Visual Prompts will not Clear; Device Operates Differently Than Expected; Device Operational Issue

  IT WAS REPORTED THAT A SYSTEM ERROR / OUT OF SERVICE / PERFORM MANUAL CPR ERROR MESSAGE WAS OBSERVED ON THE AUTOPULSE PLATFORM (SN (B)(4)) DISPLAY SCREEN. IT WAS ALSO REPORTED THAT THE PLATFORM'S METAL HOOKS ON THE UPPER HOUSING WAS BROKEN. THE ISSUE OCCURRED DURING SHIFT CHECK. NO PATIENT WAS INVOLVED WITH THIS EVENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6327833 ↗

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