AutoPulse®Resuscitation System 100 (REF 8700-0700-03)Recalls & reported problems

Summary

The FDA's MAUDE database contains 276 adverse event reports that list this exact device (DI 00849111065009), received between Aug 21, 2015 and Feb 16, 2026 — classified as 276 malfunctions.

The most frequently reported specific device problem is “Visual Prompts will not Clear” (170 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 25 most recent of 276 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 16, 2026Visual Prompts will not Clear

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24345821 ↗
• MalfunctionOct 29, 2025Display Difficult to Read; Display or Visual Feedback Problem; Display Difficult to Read; Display or Visual Feedback Problem

  DURING PREVENTATIVE MAINTENANCE, THE AUTOPULSE PLATFORM'S (SN (B)(6)) LCD HAD PARTIALLY DEAD PIXELS AND WAS UNABLE TO READ. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23418170 ↗
• MalfunctionAug 14, 2025Use of Device Problem; Use of Device Problem

  THE CUSTOMER REPORTED THAT DURING PATIENT USE OF THE AUTOPULSE PLATFORM (SN (B)(6), THEY PAUSED THE COMPRESSION AND THEN PRESSED THE START/CONTINUE BUTTON TO RESUME COMPRESSIONS, BUT IT DIDN'T. THE CUSTOMER DID NOT PROVIDE INFORMATION ON WHY THEY PAUSED THE AUTOPULSE PLATFORM OR WHETHER IT DISPLAYED ANY USER ADVISORY MESSAGES, FAULT CODES, OR PROMPTS. AFTER REMOVING AND REINSTALLING THE LIFEBAND, THE PLATFORM WAS ABLE TO RESUME COMPRESSIONS. THE CUSTOMER'S CLINICAL ENGINEER REPORTED THAT THE HINGED BELT GUARD ON THE LIFEBAND WAS DAMAGED AFTER USE. THE CUSTOMER DISCARDED THE LIFEBAND BUT PROVIDED A PICTURE THAT SHOWED THAT THE TYVEK LINER OF THE LIFEBAND HAD DETACHED FROM THE HINGED BELT GUARD. IT IS UNKNOWN IF THERE WERE ANY CONSEQUENCES OR IMPACT ON THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 22812621 ↗
• MalfunctionJul 7, 2025Visual Prompts will not Clear; Visual Prompts will not Clear

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22426216 ↗
• MalfunctionJun 24, 2025Visual 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." NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22324445 ↗
• MalfunctionApr 17, 2025Visual Prompts will not Clear; Visual Prompts will not Clear

  THE CUSTOMER REPORTED THAT 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 21853485 ↗
• MalfunctionJan 30, 2025Visual Prompts will not Clear; Visual Prompts will not Clear

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21280329 ↗
• MalfunctionJan 22, 2025Visual Prompts will not Clear; Visual Prompts will not Clear

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21213573 ↗
• MalfunctionJan 8, 2025Visual Prompts will not Clear; Visual Prompts will not Clear

  THE CUSTOMER REPORTED THAT DURING 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 21107595 ↗
• MalfunctionOct 28, 2024Use of Device Problem; Visual Prompts will not Clear; Use of Device Problem; Visual Prompts will not Clear

  THE CUSTOMER REPORTED THAT DURING SHIFT CHECK, THE AUTOPULSE PLATFORM (SN (B)(6)) DISPLAYED A "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR" ERROR MESSAGE AND DIDN'T START COMPRESSIONS. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20553050 ↗
• MalfunctionOct 2, 2024Visual Prompts will not Clear; Visual Prompts will not Clear

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20356017 ↗
• MalfunctionSep 18, 2024Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING SHIFT CHECK, THE CUSTOMER REPORTED THAT UPON POWERING ON, THE AUTOPULSE PLATFORM (B)(6) DISPLAYED A "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR" ERROR MESSAGE AND DIDN'T WORK. THE CUSTOMER RESTARTED THE PLATFORM, BUT THE ISSUE WAS NOT RESOLVED. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20249416 ↗
• MalfunctionSep 18, 2024Use of Device Problem; Use of Device Problem

  DURING PATIENT USE, THE AUTOPULSE PLATFORM (SN (B)(6) PERFORMED CHEST COMPRESSIONS ONLY ONCE, BUT THEN IT STOPPED WORKING. PER THE PARAMEDICS, THEY DID NOT CHECK THE DISPLAY PANEL AT THIS TIME, AND IT IS UNCLEAR IF AN ERROR MESSAGE WAS DISPLAYED. THE PARAMEDICS PRESSED THE START BUTTON, BUT THE PLATFORM DIDN'T RESTART CHEST COMPRESSIONS. THE PARAMEDICS PERFORMED MANUAL CPR AND TRANSPORTED THE PATIENT. THE PATIENT'S OUTCOME AND ANY OTHER INFORMATION AFTER TRANSPORTATION WERE NOT PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 20247600 ↗
• MalfunctionSep 10, 2024Visual Prompts will not Clear; Visual Prompts will not Clear

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20185702 ↗
• MalfunctionJul 3, 2024Use of Device Problem; Use of Device Problem

  THE CUSTOMER REPORTED THAT THE LOANER AUTOPULSE PLATFORM (SN (B)(6) ) POWERED UP BUT DIDN'T START COMPRESSIONS. PER THE CUSTOMER, THE PLATFORM DIDN'T DISPLAY ANY ERROR MESSAGE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19671689 ↗
• MalfunctionMay 2, 2024Use of Device Problem; Use of Device Problem

  PATIENT #1: THE AUTOPULSE PLATFORM (SN (B)(6)) WAS USED TO RESUSCITATE A PATIENT, AND THE PLATFORM PERFORMED COMPRESSIONS FOR ABOUT 25 TO 30 MINUTES WITH NO ISSUES. AFTER THE PATIENT'S USE, THE CUSTOMER NOTICED THAT THE PLATFORM WAS "EXTREMELY HOT TO THE TOUCH OF A HAND." PER THE REPORTER, NO DEVICE MALFUNCTION WAS OBSERVED ON THE PLATFORM DURING THE PATIENT'S USE, AND IT FUNCTIONED AS INTENDED. THERE WERE NO CONSEQUENCES OR IMPACTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19235253 ↗
• MalfunctionMay 2, 2024Use of Device Problem; Use of Device Problem

  PATIENT #2: THE AUTOPULSE PLATFORM (SN (B)(6)) WAS USED TO RESUSCITATE A PATIENT, AND THE PLATFORM PERFORMED COMPRESSIONS FOR ABOUT 25 TO 30 MINUTES WITH NO ISSUES. AFTER THE PATIENT'S USE, THE CUSTOMER NOTICED THAT THE PLATFORM WAS "EXTREMELY HOT TO THE TOUCH OF A HAND." PER THE REPORTER, NO DEVICE MALFUNCTION WAS OBSERVED ON THE PLATFORM DURING THE PATIENT'S USE, AND IT FUNCTIONED AS INTENDED. THERE WERE NO CONSEQUENCES OR IMPACTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19235252 ↗
• MalfunctionApr 3, 2024Visual Prompts will not Clear; Visual Prompts will not Clear

  THE CUSTOMER REPORTED THAT DURING SHIFT CHECK, THE AUTOPULSE PLATFORM (SN (B)(6)) DISPLAYED AN ERROR MESSAGE UPON POWERING UP. THE CUSTOMER DID NOT REPORT WHAT USER ADVISORY (UA) OR FAULT CODE WAS DISPLAYED. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19038841 ↗
• MalfunctionApr 1, 2024Use of Device Problem; Use of Device Problem

  ON (B)(6) 2024, DURING PREVENTIVE MAINTENANCE, THE AUTOPULSE PLATFORM (B)(6) FAILED FUNCTIONAL TESTING AS THE DRIVETRAIN MOTOR BRAKE ASSEMBLY AIR GAP WAS OUT OF SPECIFICATION. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19016806 ↗
• MalfunctionMar 25, 2024Use of Device Problem; Use of Device Problem

  DURING THE PREVENTATIVE MAINTENANCE (PM) ON (B)(6) 2024, ZOLL SERVICE PERSONNEL COULD NOT PERFORM THE FUNCTIONAL TESTING OF THE RETURNED AUTOPULSE PLATFORM (B)(6) DUE TO THE STICKY DRIVE SHAFT ROTATION. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18975562 ↗
• MalfunctionMar 7, 2024Visual Prompts will not Clear; Visual Prompts will not Clear

  THE CUSTOMER REPORTED THAT UPON POWERING ON, THE AUTOPULSE PLATFORM (SN (B)(6) DISPLAYED A USER ADVISORY (UA) 45 (NOT AT "HOME" POSITION AFTER POWER-ON/RESTART). THE CUSTOMER TRIED TO CLEAR THE ADVISORY MESSAGE BY PULLING UP THE LIFEBAND, BUT THE UA45 PERSISTED. THE CUSTOMER ATTEMPTED TO RETURN THE DRIVESHAFT TO "HOME" POSITION USING THE ADMINISTRATIVE MENU, FOLLOWING INSTRUCTIONS FROM ZOLL TECH SUPPORT. IN THE PROCESS, THE CUSTOMER CUT THE LIFEBAND (LEAVING ONLY THE BAND CLIP), TO MAKE IT EASIER TO ROTATE THE DRIVESHAFT TO "HOME" POSITION. HOWEVER, THE UA45 DID NOT CLEAR. THERE IS NO COMPLAINT OR ISSUE REPORTED ON THE LIFEBAND. THE CUSTOMER POWERED OFF/ON THE PLATFORM TO FURTHER TROUBLESHOOT THE ISSUE. UPON POWERING UP, THE PLATFORM DISPLAYED A USER ADVISORY (UA) 12 (LIFEBAND NOT PRESENT). NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18862608 ↗
• MalfunctionFeb 5, 2024Use of Device Problem; Use of Device Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18641369 ↗
• MalfunctionFeb 1, 2024Failure to Power Up; Failure to Power Up

  THE CUSTOMER REPORTED THAT THE AUTOPULSE PLATFORM SN (B)(6) DIDN'T POWER UP. THE CUSTOMER TESTED THE PLATFORM WITH FOUR FULLY CHARGED AUTOPULSE LI-ION BATTERIES THAT WERE DISPLAYING FOUR SOLID GREEN STATUS LEDS, BUT THE ISSUE PERSISTED. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18628584 ↗
• MalfunctionFeb 1, 2024Use of Device Problem; Use of Device Problem

  DURING TRAINING, AFTER THE CUSTOMER PAUSED THE LOANER AUTOPULSE PLATFORM (SN (B)(6) , THE LIFEBAND WAS UNABLE TO BE PULLED UP WHEN ATTEMPTING TO RESUME. WHEN THE CUSTOMER PRESSED THE START/CONTINUE BUTTON, THE LIFEBAND WAS PULLED UP, BUT THE PLATFORM DIDN'T RESTART COMPRESSIONS. WHEN THE CUSTOMER PRESSED THE START/CONTINUE BUTTON AGAIN, THE PLATFORM FINALLY RESTARTED COMPRESSIONS. NO PATIENT INVOLVEMENT. ZOLL SALES REPRESENTATIVE TESTED THE AUTOPULSE PLATFORM WITH ANOTHER LIFEBAND IN THE HOSPITAL. AFTER SEVERAL ATTEMPTS TO TEST THE PLATFORM, THE CLAIMED ISSUE WAS REPLICATED ONCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18628582 ↗
• MalfunctionDec 23, 2023Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING 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 18389462 ↗

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