AutoPulse®Resuscitation System 100 (REF 8700-0740-01-66)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00849111001274), received between Oct 21, 2016 and Nov 22, 2019 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (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.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 22, 2019Display Difficult to Read; Display or Visual Feedback Problem; Display Difficult to Read; Display or Visual Feedback Problem

  ON (B)(6) 2019, DURING PREVENTIVE MAINTENANCE, THE LCD SCREEN BACK-LIGHT OF THE AUTOPULSE PLATFORM (SN (B)(4)) WAS FLICKERING AND THE SCREEN WAS DIFFICULT TO READ.

  Patient problems: No Patient Involvement

  MAUDE report 9363292 ↗
• MalfunctionMay 17, 2018Visual Prompts will not Clear; Device Displays Incorrect Message; Device Operational Issue; Visual Prompts will not Clear; Device Displays Incorrect Message; Device Operational Issue

  DURING SHIFT CHECK, THE AUTOPULSE PLATFORM ((B)(4)) DISPLAYED AN UNSPECIFIED USER ADVISORY MESSAGE AND THEN "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR" MESSAGE ON THE DISPLAY SCREEN. THE USER WAS NOT ABLE TO CLEAR THE ERROR MESSAGE. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7524695 ↗
• MalfunctionMay 14, 2018Device Displays Incorrect Message; Device Operational Issue; Device Displays Incorrect Message; Device Operational Issue

  DURING PATIENT USE, THE AUTOPULSE PLATFORM ((B)(4)) PERFORMED CONTINUOUS COMPRESSION FOR AN UNSPECIFIED AMOUNT OF TIME AND THEN DISPLAYED "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR" MESSAGE. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7513042 ↗
• MalfunctionMar 23, 2018Device Displays Incorrect Message; Device Operational Issue; Device Displays Incorrect Message; Device Operational Issue

  THE USER REPORTED OBSERVING MULTIPLE ISSUES ON THE AUTOPULSE PLATFORM (SN (B)(4). FIRST OBSERVED ISSUE WAS RECURRENT USER ADVISORY (UA) 2 (COMPRESSION TRACKING ERROR) ERROR MESSAGES WHERE IT WAS NOTED THAT WHENEVER A UA 2 ERROR MESSAGE OCCURS, THE PLASTIC HOOKS ON THE SIDES OF THE PLATFORM SNAPS. THE SECOND OBSERVED ISSUE WAS USER ADVISORY (UA) 45 (DRIVESHAFT NOT AT "HOME" POSITION AFTER POWER-ON/RESTART) ERROR MESSAGES OCCURING ATLEAST MONTHLY. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7367825 ↗
• MalfunctionMar 21, 2018Device Issue; Device Displays Incorrect Message; Device Operational Issue; Device Issue; Device Displays Incorrect Message; Device Operational Issue

  DURING DEPLOYMENT, THE USER REPORTED THAT THE AUTOPULSE PLATFORM (SN (B)(4)) PERFORMED COMPRESSION EVEN BEFORE THE USER HAS NOT COMPLETED ALIGNING THE LIFEBAND. THE REPORTER ADDED THAT FOLLOWING THIS, THE PLATFORM DISPLAYED A "REALIGN LIFEBAND" PROMPT AND THEN STOPPED COMPRESSION. FOLLOWING THIS, THE USER IMMEDIATELY PERFORMED MANUAL CPR ON THE PATIENT. AFTER AN UNSPECIFIED TIME, ANOTHER CREW ARRIVED. THE PATIENT WAS TRANSFERRED TO A SECOND AUTOPULSE PLATFORM AND RECEIVED CONTINUOUS COMPRESSION WITHOUT FURTHER ISSUE REPORTED. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7360355 ↗
• MalfunctionJul 13, 2017Visual Prompts will not Clear; Device Displays Incorrect Message; Device Operational Issue; Visual Prompts will not Clear; Device Displays Incorrect Message; Device Operational Issue

  IT WAS REPORTED THAT THE AUTOPULSE PLATFORM (SN (B)(4)) DISPLAYED A RECURRENT UA 45 (DRIVESHAFT NOT AT "HOME" POSITION AFTER POWER-ON/RESTART) ERROR MESSAGE. THE REPORTER NOTED THAT THE UA 45 ERROR MESSAGE PREVIOUSLY HAD BEEN CLEARED AND THE PLATFORM HAD NOT BEEN USED. NO PATIENT WAS INVOLVED WITH THIS EVENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6712223 ↗
• MalfunctionMar 8, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  OTTAWA PARAMEDIC SERVICE RECEIVED A 911 CALL FOR A PATIENT. CLOTHES ABOVE THE WAIST WERE REMOVED, WHEN THE PLATFORM WAS PLACED. NO LEADS/CABLES/WIRES ETC. WERE NEAR OR ACROSS THE LIFEBAND. THE AUTOPULSE WAS DEPLOYED WITHOUT ANY ISSUES AND RAN FOR SEVERAL MINUTES. AS SOON AS THE PARAMEDICS UNLOADED THE STRETCHER AT THE HOSPITAL, THE PLATFORM STOPPED PERFORMING COMPRESSIONS AND ERROR MESSAGE RESET THE LIFEBAND WAS DISPLAYING. THE CUSTOMER TRIED TO PULL STRAIGHT UP AND RESET THE LIFEBAND; HOWEVER, THE LIFEBAND WOULD NOT RETRACT. UPON INSPECTION, THE CUSTOMER NOTED THAT THE LIFEBAND SHEATH WAS CAUGHT/TWISTED ON TO THE LITTLE BLACK CLIP ON THE LEFT SIDE OF THE PLATFORM CAUSING THE INTERNAL LIFEBAND TO TWIST AND JAM THE MECHANISM. THE CUSTOMER QUICKLY DISCONNECTED THE LIFEBAND AT THE MIDDLE AND RESUMED PERFORMING MANUAL CPR. NO OTHER INFORMATION WAS PROVIDED. MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE REPORTER FOR ADDITIONAL INFORMATION; HOWEVER, WERE UNSUCCESSFUL. NO FURTHER INFORMATION WAS PROVIDED. NO KNOWN PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6390145 ↗
• MalfunctionOct 25, 2016Device Displays Incorrect Message; Device Operates Differently Than Expected; Device Displays Incorrect Message; Device Operates Differently Than Expected

  DURING A TRAINING ON THE AUTOPULSE PLATFORM S/N: (B)(4), THE CUSTOMER REPORTED HEARING A LOUD SHRIEKING NOISE COMING FROM THE PLATFORM. THE PLATFORM, THEN POWERED OFF ON ITS OWN. DESPITE REPLACING THE BATTERY, THE PLATFORM DOES NOT POWER BACK ON. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 6056132 ↗
• MalfunctionOct 21, 2016Device Issue; Device Operates Differently Than Expected; Device Issue; Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING BIOMED TESTING, THE AUTOPULSE PLATFORM (S/N: (B)(4)) DISPLAYED A "SYSTEM ERROR - OUT OF SERVICE" ERROR MESSAGE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6048563 ↗

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