AutoPulse®Resuscitation System 100 (REF 8700-0730-01)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3,208 adverse event reports that list this exact device (DI 00849111000512), received between Aug 11, 2015 and Sep 30, 2026 — classified as 15 injuries, 3,193 malfunctions.

The most frequently reported specific device problem is “Visual Prompts will not Clear” (2,302 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 3,208 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Use of Device Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50954689 ↗
• MalfunctionSep 30, 2026Use of Device Problem; Noise, Audible

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50954588 ↗
• MalfunctionSep 30, 2026Visual Prompts will not Clear

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50953108 ↗
• MalfunctionSep 30, 2026Display Difficult to Read

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952397 ↗
• MalfunctionSep 28, 2026Visual Prompts will not Clear

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50925258 ↗
• MalfunctionSep 24, 2026Visual Prompts will not Clear

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50891792 ↗
• MalfunctionSep 23, 2026Visual Prompts will not Clear

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50875958 ↗
• MalfunctionSep 23, 2026Visual Prompts will not Clear

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50875699 ↗
• MalfunctionSep 23, 2026Use of Device Problem; Noise, Audible

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50875465 ↗
• MalfunctionSep 23, 2026Visual Prompts will not Clear

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50874965 ↗
• MalfunctionSep 23, 2026No Display/Image; Noise, Audible

  During device check, the AutoPulse Platform (SN (b)(6)) LCD failed to display data and generated a clicking sound when the LifeBand was connected. The AutoPulse Platform failed to operate. No patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50869923 ↗
• MalfunctionSep 21, 2026Visual Prompts will not Clear

  The AutoPulse Platform (SN (b)(6)) was deployed to resuscitate a patient. After the first compression cycle, the Platform displayed User Advisory 45 (Not at "Home" Position After Power-On/Restart). The customer attempted to clear the UA, but it persisted. Manual CPR was performed for the remainder of the call. No consequences or impacts on the patient.ZOLL tech support provided the customer with instructions on how to clear UA45 by rotating the drive shaft to the home position. ZOLL tech support has asked the customer to follow the instructions to clear the UA. Based on the additional information received, the AutoPulse Platform will be returned to ZOLL for evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50842499 ↗
• MalfunctionSep 18, 2026Visual Prompts will not Clear

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50812805 ↗
• MalfunctionSep 16, 2026Visual Prompts will not Clear

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50782503 ↗
• MalfunctionSep 15, 2026Visual Prompts will not Clear

  During the patient call, the AutoPulse Platform (SN (b)(6) displayed Fault Code 16 (Timeout Moving to Take-Up Position). The crew switched to manual CPR. Per the reporter, the patient did not survive. No additional information was provided. The customer did not provide information regarding the relationship between the death and the alleged malfunction. However, the 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 50766247 ↗
• MalfunctionMar 31, 2026Visual Prompts will not Clear

  AS REPORTED, THE AUTOPULSE PLATFORM (SN UNKNOWN) DISPLAYED A USER ADVISORY 45 (NOT AT "HOME" POSITION AFTER POWER-ON/RESTART) MESSAGE. NO ADDITIONAL INFORMATION WAS PROVIDED. IT IS UNKNOWN WHEN THE PROBLEM OCCURRED. HOWEVER, PATIENT USE INFORMATION WAS REQUESTED, BUT NO ADDITIONAL INFORMATION WAS PROVIDED. THE TROUBLESHOOTING STEPS WERE PERFORMED; HOWEVER, THE ISSUE PERSISTS.

  Patient problems: Insufficient Information

  MAUDE report 24750296 ↗
• MalfunctionMar 31, 2026Visual Prompts will not Clear

  AS REPORTED, THE AUTOPULSE PLATFORM (SN UNKNOWN) DISPLAYED A USER ADVISORY 45 (NOT AT "HOME" POSITION AFTER POWER-ON/RESTART) MESSAGE. NO ADDITIONAL INFORMATION WAS PROVIDED. IT IS UNKNOWN WHEN THE PROBLEM OCCURRED. HOWEVER, PATIENT USE INFORMATION WAS REQUESTED, BUT NO ADDITIONAL INFORMATION WAS PROVIDED. THE TROUBLESHOOTING STEPS WERE PERFORMED; HOWEVER, THE ISSUE PERSISTS.

  Patient problems: Insufficient Information

  MAUDE report 24750295 ↗
• MalfunctionMar 31, 2026Visual Prompts will not Clear

  THE CUSTOMER REPORTED THAT THE AUTOPULSE PLATFORM (SN (B)(6)) DISPLAYED USER ADVISORY 45 (NOT AT "HOME" POSITION AFTER POWER-ON/RESTART) UPON RESETTING AFTER THE PLATFORM WAS USED FOR RESUSCITATION. NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24749050 ↗
• MalfunctionMar 26, 2026Visual Prompts will not Clear

  THE AUTOPULSE PLATFORM (SN (B)(6)) DISPLAYED FAULT CODE 16 (TIMEOUT MOVING TO TAKE-UP POSITION). THE CUSTOMER TRIED A DIFFERENT LIFEBAND, BUT THE FAULT WOULD NOT CLEAR. 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 24706765 ↗
• MalfunctionMar 25, 2026Visual Prompts will not Clear

  DURING THIS CPR, THE CUSTOMER REPORTED THE AUTOPULSE PLATFORM (SN (B)(6)) WAS APPLIED CORRECTLY BUT THAT IT WOULD ONLY DO A FEW COMPRESSIONS AND THEN IT WOULD STOP. THE CREW TRIED FIXING THIS 3 TIMES. AFTER THE 3RD TIME, THE PLATFORM WOULD NOT DO ANY COMPRESSIONS. THEY WERE UNABLE TO USE IT FURTHER AT THIS EVENT. HE WAS UNSURE OF WHAT ERROR CODE OCCURRED DURING THIS EVENT. THE CREW SWITCHED TO MANUAL CPR. NO IMPACT OR CONSEQUENCE TO THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24683356 ↗
• MalfunctionMar 24, 2026Visual Prompts will not Clear

  THIS OCCURRED DURING A NEAR-WITNESSED CPR. THE PATIENT WAS PLACED ON THE AUTOPULSE PLATFORM (SN (B)(6)) CORRECTLY. NO COMPRESSIONS OCCURRED AS THE DISPLAYED ERROR MESSAGES COULD NOT BE CLEARED. THEY WERE AGAIN UNABLE TO FIX THIS IN THE MOMENT SO THEY SWITCHED TO THE LUCAS DEVICE. UPON RETURNING TO THE STATION, THEY TRIED MULTIPLE TESTS AT THE STATION AND THERE WERE SEVERAL TIMES IT DID NOT WORK. FAULT CODE 16 (TIMEOUT MOVING TO TAKE-UP POSITION) AND USER ADVISORY (UA) 23 (COMPRESSION WILL EXCEED 3 REVOLUTIONS) ERROR MESSAGES WERE OBSERVED. NO IMPACT OR CONSEQUENCE TO THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24683232 ↗
• MalfunctionMar 24, 2026Visual Prompts will not Clear

  AS REPORTED, THE AUTOPULSE PLATFORM (SN (B)(6)) DISPLAYED A USER ADVISORY (UA) 18 (MAX TAKE-UP REVOLUTIONS EXCEEDED) MESSAGE. 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 24679162 ↗
• MalfunctionMar 19, 2026Visual Prompts will not Clear

  THE CUSTOMER REPORTED DURING PATIENT USE, THE AUTOPULSE PLATFORM (SN (B)(6)) DISPLAYED USER ADVISORY (UA) 07 (DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE). PATIENT'S STATUS INFORMATION WAS REQUESTED BUT THE CUSTOMER DID NOT PROVIDE A RESPONSE.

  Patient problems: Insufficient Information

  MAUDE report 24644873 ↗
• MalfunctionMar 19, 2026Visual Prompts will not Clear

  THE CUSTOMER REPORTED THAT THE AUTOPULSE PLATFORM (SN (B)(6) DISPLAYED "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR." 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; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24640823 ↗
• MalfunctionMar 18, 2026Visual Prompts will not Clear

  THE CUSTOMER REPORTED THAT AFTER THE AUTOPULSE PLATFORM (SN 37542) WAS CLEANED FOLLOWING THE CALL AND A NEW LIFEBAND WAS INSTALLED TO RETURN THE DEVICE TO SERVICE, THE PLATFORM DISPLAYED USER ADVISORY 12 (LIFEBAND NOT PRESENT). DURING TROUBLESHOOTING, THE LIFEBAND AND THE BATTERY WERE REMOVED AND REINSTALLED MULTIPLE TIMES; HOWEVER, THE UA12 MESSAGE CONTINUED TO APPEAR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24634862 ↗

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