AutoPulse®Resuscitation System 100 (REF 8700-0740-27)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00849111001212), received between Dec 11, 2018 and Jul 16, 2020 — classified as 6 malfunctions.

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

• MalfunctionJul 16, 2020Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING SHIFT CHECK, THE AUTOPULSE PLATFORM (SN (B)(4)) DISPLAYED FAULT CODE 16 (TIMEOUT MOVING TO TAKE-UP POSITION) ERROR MESSAGE. THE PLATFORM DID NOT PERFORM COMPRESSION. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10281429 ↗
• MalfunctionApr 15, 2020Visual 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" ERROR MESSAGE UPON POWERING UP. NO FURTHER INFORMATION WAS PROVIDED ON WHETHER THE ERROR OCCURRED DURING SHIFT CHECK OR PATIENT USE. NO CONSEQUENCES OR IMPACT TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9965569 ↗
• MalfunctionMar 27, 2020Use of Device Problem; Use of Device Problem

  NO LED LIGHTS ILLUMINATED ON THE AUTOPULSE LI-ION BATTERY (SN: (B)(4)) WHEN THE BATTERY STATUS BUTTON WAS PRESSED. THE AUTOPULSE PLATFORM DOESN'T FUNCTION WHEN IT IS POWERED ON WITH THIS BATTERY. IT IS UNKNOWN WHEN THE REPORTED ISSUE OCCURRED. HOWEVER, THERE WAS NO REPORT OF PATIENT CONSEQUENCES, AND THE CUSTOMER DIDN'T PROVIDE ANY FURTHER INFORMATION. PLEASE SEE THE FOLLOWING RELATED MFR REPORT: MFR # 3010617000-2020-00370 FOR THE AUTOPULSE LI-ION BATTERY (SN: (B)(4)).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9892345 ↗
• MalfunctionJan 10, 2020Use of Device Problem; Use of Device Problem

  ON DECEMBER 16, 2019, DURING PREVENTIVE MAINTENANCE, THE AUTOPULSE PLATFORM (SN (B)(4)) STOPPED COMPRESSIONS DURING INITIAL FUNCTIONAL TESTING. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9578668 ↗
• MalfunctionNov 11, 2019Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING SHIFT CHECK, THE AUTOPULSE PLATFORM (SN: (B)(4)) DISPLAYED USER ADVISORY, UA17 (MAX MOTOR ON TIME EXCEEDED DURING ACTIVE OPERATION) ERROR MESSAGE. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9306221 ↗
• MalfunctionDec 11, 2018Visual Prompts will not Clear; Visual Prompts will not Clear

  AS REPORTED, DURING SHIFT CHECK, THE AUTOPULSE PLATFORM (B)(4) DISPLAYED UA41 (PATIENT TEMPERATURE SENSOR FAILURE) ERROR MESSAGE AND THE USER WAS UNABLE TO CLEAR THE ERROR MESSAGE. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8151739 ↗

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