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AutoPulse®Resuscitation System 100 (REF 8700-0740-24)Recalls & reported problems

Zoll Circulation, Inc. · The AutoPulse System consists of 4 primary components, a reusable Platform, a single use chest compression assembly (LifeBand), a rechargeable battery, and a battery charger. · Class 2

All models of AutoPulseResuscitation System (46)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
7
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00849111001151), received between Jul 30, 2020 and May 23, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Visual Prompts will not Clear” (6 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 18, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 1 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Visual Prompts will not Clear6
  • Use of Device Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions5
  • Insufficient Information1
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 23, 2025Use of Device Problem; Use of Device Problem

    BUSINESS PARTNER REPORTED THAT THE CUSTOMER'S AUTOPULSE PLATFORM (SN (B)(6)) DOES NOT ADJUST THE LIFEBAND. THE CUSTOMER TESTED THE PLATFORM WITH THE NEW LIFEBAND, BUT THE ISSUE PERSISTED. 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 22081050 ↗
  • MalfunctionApr 28, 2023Visual Prompts will not Clear; Visual Prompts will not Clear

    DURING THE SHIFT CHECK, THE AUTOPULSE PLATFORM (SN (B)(4)) DISPLAYED USER ADVISORY (UA) 28 (LOSS OF CLUTCH CONNECTIVITY) AND FAULT CODE 29 (LOSS OF BRAKE CONNECTIVITY) ERROR MESSAGES, AND THE PLATFORM WILL NOT PERFORM CHEST COMPRESSIONS. NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16839985 ↗
  • MalfunctionMar 2, 2022Visual Prompts will not Clear; Visual Prompts will not Clear

    DURING PREVENTIVE MAINTENANCE (PM) ON (B)(6) 2022, THE AUTOPULSE PLATFORM (SN (B)(4)) FAILED FUNCTIONAL TESTING DUE TO UA11 (MAX PATIENT TEMPERATURE EXCEEDED) AND UA41 (PATIENT TEMPERATURE SENSOR FAILURE) ERROR MESSAGES. NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13645811 ↗
  • MalfunctionAug 15, 2021Visual Prompts will not Clear; Visual Prompts will not Clear

    AFTER PATIENT USE, THE AUTOPULSE PLATFORM (SERIAL #(B)(4)) DISPLAYED USER ADVISORY "(UA)02" (COMPRESSION TRACKING ERROR) ERROR MESSAGE. NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12322305 ↗
  • MalfunctionJul 31, 2021Visual Prompts will not Clear; Visual Prompts will not Clear

    DURING THE PATIENT CALL, THE CUSTOMER REPORTING THE CONTAMINATION OF THE BODILY FLUIDS INSIDE OF THE AUTOPULSE PLATFORM. IN ADDITION, THE AUTOPULSE PLATFORM (SN (B)(4)) DISPLAYED A FAULT CODE 08 (MOTOR CONTROLLER FAULT DETECTED). NO FURTHER INFORMATION WAS PROVIDED. NO CONSEQUENCES OR IMPACT TO PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12257233 ↗
  • MalfunctionSep 11, 2020Visual Prompts will not Clear; Visual Prompts will not Clear

    CUSTOMER REPORTED THAT THE AUTOPULSE PLATFORM (SERIAL #(B)(4) DISPLAYED FAULT CODE 16 (TIMEOUT MOVING TO TAKE-UP POSITION) ERROR MESSAGE. NO FURTHER INFORMATION WAS PROVIDED. PATIENT USE INFORMATION WAS REQUESTED BUT NO ADDITIONAL INFORMATION WAS PROVIDED, THEREFORE PATIENT USE IS UNKNOWN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 10525657 ↗
  • MalfunctionJul 30, 2020Visual Prompts will not Clear; Visual Prompts will not Clear

    DURING DEPLOYMENT FOR PATIENT USE, CUSTOMER REPORTED THAT THE AUTOPULSE PLATFORM (SERIAL #(B)(4)) DISPLAYED FAULT CODE 16 (TIMEOUT MOVING TO TAKE-UP POSITION) ERROR MESSAGE UPON POWER UP. USER WAS UNABLE TO CLEAR ERROR MESSAGE. ANOTHER AUTOPULSE PLATFORM WAS USE TO CONTINUE WITH COMPRESSION. NO CONSEQUENCES OR IMPACT TO PATIENT WAS REPORTED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10348330 ↗

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

Other Compressor, Cardiac, External devices

All Compressor, Cardiac, External devices →

Sources and updates

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