AutoPulse®Resuscitation System 100 (REF 8700-0730-16)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00849111000574), received between Oct 6, 2016 and Apr 8, 2022 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Visual Prompts will not Clear” (8 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.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2022Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING SHIFT CHECK, THE CUSTOMER REPORTED THE AUTOPULSE PLATFORM(SN (B)(4) DISPLAYED USER ADVISORY (UA) 07 (DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE) ERROR MESSAGE IMMEDIATELY UPON POWERING ON. THE CUSTOMER REPLACED THE LIFEBAND BUT THE PLATFORM AGAIN DISPLAYED (UA) 07 UPON POWERING ON. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14060426 ↗
• MalfunctionFeb 22, 2022Display Difficult to Read; Display or Visual Feedback Problem; Display Difficult to Read; Display or Visual Feedback Problem

  DURING PREVENTATIVE MAINTENANCE (PM) OF THE AUTOPULSE PLATFORM (S/N (B)(4)), THE LCD SCREEN WAS DARK/UNREADABLE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13581999 ↗
• MalfunctionDec 24, 2021Visual Prompts will not Clear; Visual Prompts will not Clear

  THE AUTOPULSE PLATFORM (SN (B)(4)) DISPLAYED "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR ". IT IS UNKNOWN WHERE THE PROBLEM OCCURRED. HOWEVER, PATIENT USE INFORMATION WAS REQUESTED BUT NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 13083218 ↗
• MalfunctionDec 11, 2020Use of Device Problem; Use of Device Problem

  DURING INVESTIGATION OF THE RETURNED AUTOPULSE PLATFORM (SN (B)(4) ON (B)(6) 2020, OBSERVED SEIZED BRAKE GAP UPON POWERING ON. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10992608 ↗
• MalfunctionJul 24, 2020Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING SHIFT CHECK, WHILE INSTALLING AN AUTOPULSE LIFEBAND, THE AUTOPULSE PLATFORM (SN: 50039) DISPLAYED USER ADVISORY (UA) 45 (NOT AT "HOME" POSITION AFTER POWER-ON/RESTART) ERROR MESSAGE. THE LIFEBAND WAS REPLACED TO TROUBLESHOOT THE PROBLEM; HOWEVER, THE ISSUE WAS NOT RESOLVED. IN ADDITION, THE PLATFORM WAS DROPPED BY THE CUSTOMER, AND IT WAS NOTED THAT THE TOP COVER WAS CRACKED. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10323456 ↗
• MalfunctionJun 30, 2020Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING SHIFT CHECK, THE AUTOPULSE PLATFORM (SN (B)(4)) DISPLAYED UA 18 (MAX TAKE-UP REVOLUTIONS EXCEEDED) ERROR MESSAGE. IN ADDITION, CRACKED ENCODER COVER WAS OBSERVED. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10215909 ↗
• MalfunctionApr 2, 2019Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING THE SHIFT CHECK, THE AUTOPULSE PLATFORM (SN (B)(4)) DISPLAYED A USER ADVISORY (UA) 18 (MAX TAKE-UP REVOLUTIONS EXCEEDED) ERROR MESSAGE. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8476461 ↗
• MalfunctionJan 29, 2019Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING TESTING ON A MANNEQUIN, THE AUTOPULSE PLATFORM (SN (B)(4)) DISPLAYED A USER ADVISORY (UA) 17 (MOTOR ON FOR TOO LONG DURING ACTIVE OPERATION) ERROR MESSAGE. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8287632 ↗
• MalfunctionJan 16, 2019Visual Prompts will not Clear; Visual Prompts will not Clear

  IT WAS REPORTED THAT DURING A SHIFT CHECK, THE AUTOPULSE PLATFORM ((B)(4)) DISPLAYED USER ADVISORY (UA) 28 (LOSS OF CLUTCH CONNECTIVITY) ERROR MESSAGE. NO PATIENT INVOLVED WITH THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8254524 ↗
• MalfunctionOct 28, 2018Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING DEVICE CHECK, THE AUTOPULSE PLATFORM DISPLAYED ERROR MESSAGE USER ADVISORY (UA) 07 (DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE). NO PATIENT WAS INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 8011384 ↗
• MalfunctionOct 6, 2016Activation, Positioning or Separation Problem; Device Operates Differently Than Expected; Activation, Positioning or Separation Problem; Device Operates Differently Than Expected

  DURING A PRODUCT DEMONSTRATION IT WAS REPORTED THAT THE CUSTOMER INSERTED A BATTERY INTO THE AUTOPULSE PLATFORM (S/N: (B)(4)) AND THE DEVICE DID NOT POWER ON. DESPITE REPLACING THE BATTERY MULTIPLE TIMES, THE ISSUE WAS NOT RESOLVED. ACCORDING TO THE REPORTER, IT WAS LATER DISCOVERED THAT THE CUSTOMER DID NOT REMOVE THE BLACK BATTERY PIN COVER PRIOR TO INSERTING IT INTO THE PLATFORM AND MAY HAVE BROKEN SOMETHING INSIDE. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 6006147 ↗

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