AutoPulse®Resuscitation System 100 (REF 8700-0700-03-66)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00849111065108), received between Feb 4, 2016 and Nov 20, 2023 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 20, 2023Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING PREVENTATIVE MAINTENANCE (PM), THE AUTOPULSE PLATFORM (B)(6) FAILED FUNCTIONAL TESTING AND DISPLAYED USER ADVISORY (UA) 19 (MAX APPLIED LOAD EXCEEDED). NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18177426 ↗
• MalfunctionApr 3, 2018Device Operates Differently Than Expected; Device Operational Issue; Device Operates Differently Than Expected; Device Operational Issue

  DURING SHIFT CHECK, THE AUTOPULSE PLATFORM (SN (B)(4)) WILL NOT START COMPRESSIONS AFTER IT WAS PUT ON PAUSE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7394757 ↗
• MalfunctionJan 26, 2018Device Stops Intermittently; Device Operates Differently Than Expected; Device Operational Issue; Device Stops Intermittently; Device Operates Differently Than Expected; Device Operational Issue

  DURING PATIENT USE, CUSTOMER REPORTED THAT THE AUTOPULSE STOPPED COMPRESSIONS AFTER SEVERAL MINUTES OF OPERATION. THE CREW IMMEDIATELY SWITCHED TO LUCAS CHEST COMPRESSION SYSTEM. NO PATIENT HARM OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7223504 ↗
• MalfunctionJan 23, 2018Visual Prompts will not Clear; Device Displays Incorrect Message; Device Operates Differently Than Expected; Device Operational Issue; Visual Prompts will not Clear; Device Displays Incorrect Message; Device Operates Differently Than Expected; Device Operational Issue

  DURING PATIENT USE, THE CUSTOMER PRESSED THE START BUTTON ON AUTOPULSE PLATFORM (B)(4).; HOWEVER, THE UNIT FROZE AND WAS DISPLAYING AN ERROR MESSAGE "ANALYZING PATIENT SIZE". THE PLATFORM ALSO DID NOT ADJUST THE LIFEBAND. THE CREW THEN REVERTED TO MANUAL CPR. NO ADVERSE CONSEQUENCES WERE REPORTED. THIS IS REPORT FOR AUTOPULSE PLATFORM. FOR AUTOPULSE LIFEBAND (LOT# 71760) ISSUE SEE MFR 3010617000-2018-00125.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7214339 ↗
• MalfunctionDec 5, 2016Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT THE LOANER AUTOPULSE PLATFORM (SN: (B)(4)) TOP COVER'S WIRE STRANDS WERE BROKEN OFF. DURING INVESTIGATION, MULTIPLE USER ADVISORY 07 (DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE) ERROR MESSAGE WERE DISPLAYING. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 6146666 ↗
• MalfunctionOct 4, 2016Visual Prompts will not Clear; Device Displays Incorrect Message; Visual Prompts will not Clear; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING A SHIFT CHECK, THE AUTOPULSE PLATFORM (S/N: (B)(4)) DISPLAYED SYSTEM ERROR UPON POWERING ON. WHEN AZM-TS (TECHNICAL SERVICES (B)(4)) RECEIVED THE DEVICE ,THEY CONFIRMED SYSTEM ERROR 132 MESSAGE. NO PATIENT INVOLVEMENT WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5998854 ↗
• MalfunctionFeb 4, 2016Device Stops Intermittently; Visual Prompts will not Clear; Device Displays Incorrect Message; Device Operates Differently Than Expected; Device Stops Intermittently; Visual Prompts will not Clear; Device Displays Incorrect Message; Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING PATIENT USE THE AUTOPULSE PLATFORM (S/N (B)(4)) STOPPED FUNCTIONING AFTER 3-4 COMPRESSIONS. THE CUSTOMER REPEATED THE RESTART PROCESS A FEW TIMES UNTIL THE DEVICE DISPLAYED A SYSTEM ERROR AT WHICH TIME THE USE OF THE AUTOPULSE WAS SUSPENDED. THE CREW HAD TO REVERT TO MANUAL CPR. NO PATIENT INFORMATION WAS DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5411791 ↗

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