AutoPulse®Resuscitation System 100 (REF 8700-0740-02)Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 00849111001052), received between Aug 11, 2015 and May 7, 2025 — classified as 47 malfunctions.

The most frequently reported specific device problem is “Visual Prompts will not Clear” (32 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 25 most recent of 47 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2025Visual Prompts will not Clear; Visual Prompts will not Clear

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21981924 ↗
• MalfunctionNov 26, 2024Use of Device Problem; Visual Prompts will not Clear; Use of Device Problem; Visual Prompts will not Clear

  UPON BEING DISPATCHED TO A CARDIAC ARREST AT A RESIDENCE, THE CUSTOMER DEPLOYED THE AUTOPULSE PLATFORM (SN (B)(6) TO PROVIDE AUTOMATED CPR TO THE PATIENT. AFTER DELIVERING FIVE COMPRESSIONS, THE AUTOPULSE STOPPED, DISPLAYING A MESSAGE OF "REALIGN PATIENT" AND "PULL UP LIFEBAND". THE CREW REALIGNED THE PATIENT, ENSURING THE YELLOW IDENTIFICATION MARKER WAS VISIBLE UNDER THE PATIENT'S ARMPIT, BUT THE AUTOPULSE WOULD NOT RESTART. DESPITE FOUR MORE ATTEMPTS TO ADJUST THE LIFEBAND AND INSPECT THE PATIENT'S POSITIONING, THE LIFEBAND FAILED TO RETRACT AND FUNCTION. CONSEQUENTLY, THE EMS CREW REVERTED TO MANUAL CPR. NO CONSEQUENCES OR IMPACTS ON THE PATIENT. AFTER THE CALL, THE CUSTOMER INSPECTED THE AUTOPULSE PLATFORM AND LIFEBAND, WHICH REVEALED NO VISIBLE DAMAGE OR ISSUES. THE CUSTOMER MENTIONED THAT THE ISSUE MIGHT HAVE BEEN DUE TO USER ERROR OR A PROBLEM WITH THE LIFEBAND, BUT IT'S DIFFICULT TO DETERMINE SINCE THE LIFEBAND USED AT THE TIME WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20778681 ↗
• MalfunctionMar 6, 2024Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING SERVICING FOR PREVENTIVE MAINTENANCE ON 02/13/24, THE AUTOPULSE PLATFORM (SN (B)(6)) DISPLAYED USER ADVISORY (UA) 45 (NOT AT "HOME" POSITION AFTER POWER-ON/RESTART) ERROR MESSAGE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18853052 ↗
• MalfunctionNov 2, 2023Use of Device Problem; Unexpected Shutdown; Use of Device Problem; Unexpected Shutdown

  THE CUSTOMER REPORTED THAT THE AUTOPULSE PLATFORM POWERED OFF DURING COMPRESSION AND THAT THE MAINTENANCE MENU WAS INACCESSIBLE. NO FURTHER INFORMATION WAS PROVIDED. IT IS UNKNOWN WHEN THE PROBLEM OCCURRED. HOWEVER, PATIENT USE INFORMATION WAS REQUESTED, BUT NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 18062272 ↗
• MalfunctionOct 20, 2023Visual Prompts will not Clear; Visual Prompts will not Clear

  THE CUSTOMER REPORTED THAT THE AUTOPULSE PLATFORM (SN 40664) DISPLAYED "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR " ERROR MESSAGE IMMEDIATELY UPON POWERING ON. ALSO THE UPPER CASE IS BROKEN. IT IS UNKNOWN WHEN THE PROBLEM OCCURRED. HOWEVER, PATIENT USE INFORMATION WAS REQUESTED BUT NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 17978094 ↗
• MalfunctionMay 26, 2023Visual Prompts will not Clear; Visual Prompts will not Clear

  CUSTOMER REPORTED THAT THE AUTOPULSE PLATFORM (SERIAL #(B)(6)) DISPLAYED "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR " MESSAGE. 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 17011477 ↗
• MalfunctionNov 14, 2022Visual 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" UPON POWERING UP. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15794850 ↗
• MalfunctionAug 24, 2022Visual Prompts will not Clear; Visual Prompts will not Clear

  THE CUSTOMER REPORTED THAT THE AUTOPULSE PLATFORM (S/N (B)(4)) DISPLAYED USER ADVISORY (UA) 21 (POSITION CHANGE DOES NOT COINCIDE WITH MOTOR DIRECTION) ERROR MESSAGE. 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 15283395 ↗
• MalfunctionJun 27, 2022Use of Device Problem; Visual Prompts will not Clear; Use of Device Problem; Visual Prompts will not Clear

  DURING THE PREVENTIVE MAINTENANCE (PM) ON (B)(6) 2022, THE AUTOPULSE PLATFORM (SN (B)(4)FAILED INITIAL FUNCTIONAL TESTING DUE TO FAULT 41 (PATIENT TEMPERATURE SENSOR FAILURE) AND FAILED BRAKE GAP INSPECTION. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14831206 ↗
• MalfunctionJun 10, 2022Use of Device Problem; Visual Prompts will not Clear; Use of Device Problem; Visual Prompts will not Clear

  THE CUSTOMER REPORTED THAT THE AUTOPULSE PLATFORM (S/N (B)(4)) DISPLAYED USER ADVISORY (UA) 20 (POSITION OUT OF RANGE). IN ADDITION, THE CUSTOMER STATED THAT THE AUTOPULSE PLATFORM BEGAN HEATING AFTER 1 HOUR AND 30 MINUTES OF USE, AND SUDDENLY THE PLATFORM STOPPED COMPRESSION WITH THE UA20 ADVISORY MESSAGE. THE CUSTOMER ALSO REPORTED A SMELL OF BURNING FROM THE PLATFORM. NO FURTHER INFORMATION WAS PROVIDED. IT IS UNKNOWN WHEN THE PROBLEM OCCURRED. HOWEVER, PATIENT USE INFORMATION WAS REQUESTED, BUT NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 14658510 ↗
• MalfunctionFeb 17, 2022Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING ZOLL'S INVESTIGATION ON 01/24/22, THE AUTOPULSE PLATFORM (B)(4) DISPLAYED USER ADVISORY - "(UA)07" (DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE) ERROR MESSAGE UPON PLATFORM POWERING ON. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13550272 ↗
• MalfunctionDec 3, 2021Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING PREVENTIVE MAINTENANCE ON (B)(6) 2021, THE AUTOPULSE PLATFORM (SN (B)(4)) FAILED FUNCTIONAL TESTING DUE TO THE FAULT CODE 8 (MOTOR CONTROLLER FAULT DETECTED) ERROR MESSAGE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12930117 ↗
• MalfunctionSep 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) DISPLAYED A "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR" ERROR MESSAGE UPON POWERING ON. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12494912 ↗
• MalfunctionSep 17, 2021Use of Device Problem; Use of Device Problem

  DURING PREVENTIVE MAINTENANCE ON (B)(6) 2021, THE STIFF MANUAL ROTATION OF THE DRIVESHAFT WAS NOTED ON THE AUTOPULSE PLATFORM (B)(4). NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12486207 ↗
• MalfunctionSep 17, 2021Unexpected Shutdown; Unexpected Shutdown

  DURING PREVENTIVE MAINTENANCE ON (B)(6) 2021, THE AUTOPULSE PLATFORM (B)(4) POWERED OFF DURING THE FUNCTIONAL TESTING. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12486205 ↗
• MalfunctionSep 17, 2021Use of Device Problem; Visual Prompts will not Clear; Use of Device Problem; Visual Prompts will not Clear

  DURING PREVENTIVE MAINTENANCE ON (B)(6) 2021, THE STIFF MANUAL ROTATION OF THE DRIVESHAFT WAS NOTED ON THE AUTOPULSE PLATFORM (B)(4). IN ADDITION DURING FURTHER TESTING, THE PLATFORM FAILED THE FUNCTIONAL TEST DUE TO THE FAULT CODE 16 (TIMEOUT MOVING TO TAKE-UP POSITION). NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12486181 ↗
• MalfunctionSep 16, 2021Visual Prompts will not Clear; Visual Prompts will not Clear

  ON (B)(6) 2021, DURING PREVENTIVE MAINTENANCE, THE RETURNED AUTOPULSE PLATFORM (B)(4) DISPLAYED USER ADVISORY (UA)02 (COMPRESSION TRACKING ERROR) DURING THE INITIAL FUNCTIONAL TESTING. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12482335 ↗
• MalfunctionAug 30, 2021Visual Prompts will not Clear; Visual Prompts will not Clear

  UPON RECEIPT OF THE DEVICE, CUSTOMER REPORTED THAT THE AUTOPULSE PLATFORM (SERIAL #(B)(4)) DISPLAYED "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR " UPON POWERING ON. IN ADDITION, THE PLATFORM MAKES LOUD CLACKING SOUNDS. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12387885 ↗
• MalfunctionJul 15, 2021Use of Device Problem; Use of Device Problem

  ON (B)(6) 2021, DURING PREVENTIVE MAINTENANCE OF THE AUTOPULSE PLATFORM (SERIAL #(B)(4)), ZOLL SERVICE PERSONNEL NOTICED THAT ONE OF THE LOAD CELL READINGS EXCEEDED THE PARAMETERS. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12178236 ↗
• MalfunctionJul 13, 2021Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING PATIENT USE, THE AUTOPULSE PLATFORM (SERIAL # (B)(4)) POWERED OFF AFTER POWERING IT ON. THE NURSE REPLACED THE AUTOPULSE LI-ION BATTERY ON THE AUTOPULSE PLATFORM AND DURING POWER ON, THE PLATFORM DISPLAYED FAULT CODE 16 (TIMEOUT MOVING TO TAKE-UP POSITION) ERROR MESSAGE. PATIENT DEATH WAS REPORTED. THE CUSTOMER DID NOT PROVIDE INFORMATION REGARDING THE RELATIONSHIP BETWEEN THE DEATH AND THE ALLEGED MALFUNCTION. HOWEVER, ZOLL'S MEDICAL SAFETY ASSESSMENT (MSA) EVALUATED THE INCIDENT, AND IT WAS DETERMINED THAT THE DEATH WAS NOT RELATED TO THE AUTOPULSE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12156299 ↗
• MalfunctionDec 3, 2020Visual Prompts will not Clear; Visual Prompts will not Clear

  ON (B)(6) 2020, DURING PREVENTIVE MAINTENANCE, THE AUTOPULSE PLATFORM (SERIAL#: (B)(4)) FAILED THE LOAD CELL CHARACTERIZATION TEST, LOAD CELL MODULE 2 WAS OVER REPORTED (DEFECTIVE). NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10939821 ↗
• MalfunctionDec 1, 2020Use of Device Problem; Use of Device Problem

  DURING INVESTIGATION PERFORMED ON 10 NOVEMBER 2020, THE AUTOPULSE PLATFORM (SN: (B)(4)) FAILED THE LOAD CELL CHARACTERIZATION TEST DURING THE FUNCTIONAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10925439 ↗
• MalfunctionNov 4, 2020Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING TRAINING, THE LIFEBAND (LOT #: 97059) WAS UNABLE TO BE RETRACTED, AND THE AUTOPULSE PLATFORM (SN: (B)(4)) DISPLAYED AN UNKNOWN USER ADVISORY (UA) ERROR MESSAGE. THE CUSTOMER REPORTED THAT THE LIFEBAND WAS OBSERVED DAMAGED ON THE STITCHES NEAR THE BELT CLIP. IT WAS ALSO REPORTED THAT THE BLACK PLASTIC LATCH OF THE AUTOPULSE LIFEBAND WAS BROKEN. NO PATIENT INVOLVEMENT. AS PER THE CUSTOMER, A SIMILAR ISSUE WAS OBSERVED ON DIFFERENT USER TRAINING SESSIONS. PLEASE SEE THE FOLLOWING RELATED MFR REPORT: MFR # 3010617000-2020-01112 FOR THE LIFEBAND (LOT # 97059).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10783142 ↗
• MalfunctionSep 18, 2020Use of Device Problem; Use of Device Problem

  DURING DEVICE TESTING BY BIOMED, THE LIFEBAND DOES NOT RETRACT ON THE AUTOPULSE PLATFORM (SERIAL #(B)(4). STIFF ROTATION OF THE DRIVESHAFT ON THE AUTOPULSE PLATFORM. NO PATIENT INVOLVEMENT. PLEASE SEE THE FOLLOWING RELATED MFR REPORT: MFR 3010617000-2020-00997 FOR THE LIFEBAND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10557376 ↗
• MalfunctionJun 18, 2020Use of Device Problem; Use of Device Problem

  DURING PATIENT USE, THE AUTOPULSE PLATFORM (SN: (B)(4)) STOPPED FUNCTIONING AND TURNED OFF AFTER PERFORMING A FEW COMPRESSIONS. IN ADDITION, THE CUSTOMER REPORTED THAT AUTOPULSE LI-ION BATTERY (SN: (B)(4)) WAS STUCK IN THE BATTERY COMPARTMENT OF THE AUTOPULSE PLATFORM. AS PER THE CUSTOMER, THERE WERE NO BREAKAGES OBSERVED ON EITHER THE BATTERY FINGER LATCH OR ON THE AUTOPULSE BATTERY COMPARTMENT. NO CONSEQUENCES OR IMPACT TO THE PATIENT. PLEASE SEE THE FOLLOWING RELATED MFR REPORT: MFR # 3010617000-2020-00623 FOR THE AUTOPULSE LI-ION BATTERY (SN: (B)(4)).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10172189 ↗

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