AutoPulse®Resuscitation System 100 (REF 8700-0700-02-66)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00849111000314), received between Jul 15, 2016 and Sep 18, 2019 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Visual Prompts will not Clear” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2019Visual Prompts will not Clear; Visual Prompts will not Clear

  THE AUTOPULSE PLATFORM DISPLAYED "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR" ERROR MESSAGE UPON POWERING ON. NO ADDITIONAL INFORMATION WAS PROVIDED. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9084810 ↗
• MalfunctionJul 26, 2019Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING SHIFT CHECK, CUSTOMER REPORTED THAT THE AUTOPULSE PLATFORM (SERIAL #(B)(4)) DISPLAYED A USER ADVISORY - "(UA) 45" (DRIVESHAFT NOT AT "HOME" POSITION AFTER POWER-ON/RESTART) MESSAGE DURING POWER ON. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8834308 ↗
• MalfunctionAug 7, 2018Visual Prompts will not Clear; Visual Prompts will not Clear

  AS REPORTED, DURING PRODUCT TRAINING, THE USER'S AUTOPULSE PLATFORM ((B)(4)) DISPLAYED USER ADVISORY - UA 07 (DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE) ERROR MESSAGE. THE USERS WERE UNABLE TO CLEAR THE ERROR MESSAGE. A ZOLL SALE REPRESENTATIVE WENT ON-SITE AND ATTEMPTED TO RUN A SIMULATION ON A MANNEQUIN BUT WITHOUT SUCCESS. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7760187 ↗
• MalfunctionJun 25, 2018Device Displays Incorrect Message; Device Operational Issue; Device Displays Incorrect Message; Device Operational Issue

  THE AUTOPULSE PLATFORM (SN (B)(4) ) DISPLAYED A "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR" MESSAGE UPON POWER UP. THE REPORTER WAS UNABLE TO SPECIFY IF THE ISSUE OCCURRED DURING SHIFT CHECK OR PATIENT USE. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7636488 ↗
• MalfunctionApr 24, 2018Visual Prompts will not Clear; Device Displays Incorrect Message; Visual Prompts will not Clear; Device Displays Incorrect Message

  AS REPORTED DURING SHIFT CHECK, THE AUTOPULSE PLATFORM ((B)(4)) WAS DISPLAYING ERROR MESSAGE USER ADVISORY (UA) 12 (LIFEBAND NOT PRESENT) AND USER ADVISORY (UA) 45 (NOT AT "HOME" POSITION AFTER POWER-ON/RESTART). THE FIELD SERVICE TECHNICIAN TRIED TO CLEAR THE ERROR BY POWER CYCLING THE PLATFORM SEVERAL TIMES AND REPLACING THE LIFEBANDS; HOWEVER, THE USER ADVISORY (UA) 12 ERROR MESSAGE PERSISTED. ACCORDING TO THE TECHNICIAN, THE MAIN SHAFT DOES NOT ROTATE SMOOTHLY. NO PATIENT INVOLVEMENT ON THIS ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 7457068 ↗
• MalfunctionJul 15, 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 USER ADVISORY (UA) 20 (POSITION OUT OF RANGE) ERROR MESSAGE. TO TROUBLESHOOT THE ISSUE THE BIOMED TRIED ROTATING THE DRIVE TRAIN, HOWEVER THIS DID NOT RESOLVE THE ISSUE. NO PATIENT INVOLVED DURING THIS EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 5797193 ↗

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