AutoPulse®Resuscitation System 100 (REF 8700-0730-24)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00849111000659), received between Sep 16, 2015 and Oct 20, 2023 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (3 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 20, 2023Use of Device Problem; Use of Device Problem

  THE CUSTOMER REPORTED THAT THE AUTOPULSE PLATFORM (B)(6) DID NOT RETRACT THE LIFEBAND UPON POWERING ON DURING SHIFT CHECK. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17977237 ↗
• MalfunctionMay 3, 2023Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING SHIFT CHECK, THE AUTOPULSE PLATFORM (B)(6) DISPLAYED A USER ADVISORY (UA) 45 (NOT AT "HOME" POSITION AFTER POWER-ON/RESTART) ERROR MESSAGE. ADDITIONALLY, THE CUSTOMER REPORTED WHEN TRYING TO FULLY LIFT/EXTEND THE LIFEBAND, A LOT OF FORCE IS REQUIRED. WHEN INSERTING THE BELT CLIP TEST, THE DRIVE SHAFT DOES NOT ROTATE FREELY IN BOTH DIRECTIONS. ON EVALUATION, BIOMED FOUND THAT THE MOTOR SHAFT IS BENT, AND THE CLUTCH DOES NOT TURN EVENLY. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16862965 ↗
• MalfunctionMay 20, 2021Use of Device Problem; Use of Device Problem

  DURING SHIFT CHECK, CUSTOMER REPORTED THAT THE AUTOPULSE PLATFORM SERIAL #(B)(4) DOES NOT RETRACT THE LIFEBAND. PER CUSTOMER, THE PLATFORM DID NOT DISPLAY ANY ERROR MESSAGE DURING THE REPORTED EVENT. THE CUSTOMER TESTED THE LIFEBAND WITH ANOTHER AUTOPULSE PLATFORM AND THE LIFEBAND WORKED AS INTENDED. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11861027 ↗
• MalfunctionMay 15, 2021Use of Device Problem; Use of Device Problem

  THE CUSTOMER REPORTED THAT THE DRIVESHAFT OF THE AUTOPULSE PLATFORM S/N (B)(4) WAS STIFF, NOT ROTATING FREELY. NO FURTHER INFORMATION WAS PROVIDED. PATIENT USE INFORMATION WAS REQUESTED, BUT NO ADDITIONAL INFORMATION WAS PROVIDED. THEREFORE, PATIENT USE IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 11829690 ↗
• MalfunctionFeb 11, 2021Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING SHIFT CHECK, THE AUTOPULSE PLATFORM ((B)(4)) DISPLAYED USER ADVISORY (UA) 7 (DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE) ERROR MESSAGE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11319307 ↗
• MalfunctionApr 11, 2019Visual Prompts will not Clear; Visual Prompts will not Clear

  AS REPORTED, THE AUTOPULSE PLATFORM (SN (B)(4)) DISPLAYED USER ADVISORY (UA) 17 (MAX MOTOR ON TIME EXCEEDED DURING ACTIVE OPERATION) ERROR MESSAGE. UNKNOWN IF THE DEVICE ISSUE WAS OBSERVED DURING THE PATIENT USE OR DEVICE CHECK. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8507267 ↗
• MalfunctionNov 15, 2015Device Inoperable

  IT WAS REPORTED THAT THE MOTOR FOR TWO AUTOPULSE PLATFORMS (S/N'#S) (B)(4) WERE NOT WORKING AND NO COMPRESSIONS WERE ABLE TO BE PERFORMED. THERE WAS NO REPORT OF ANY PATIENT INVOLVEMENT. NO ADDITIONAL DETAILS WERE PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 5223912 ↗
• MalfunctionOct 15, 2015No Display/Image

  IT WAS REPORTED THAT THE AUTOPULSE CONTROL PANEL DOES NOT ILLUMINATE OR DISPLAY. THE AUTOPULSE PLATFORM WAS TURNED ON, THE LED LIGHTS THE BOARD. THE BATTERY IS DISPLAYING THE LEDS INDICATING IT IS WORKING PROPERLY. HOWEVER THE CONTROL PANEL IS BLANK. THERE WAS NO REPORT OF PATIENT INVOLVEMENT DURING THIS EVENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 5154540 ↗
• MalfunctionOct 15, 2015Device Displays Incorrect Message

  IT WAS REPORTED THAT WHEN THE AUTOPULSE PLATFORM WAS POWERED ON, THE USER CONTROL PANEL AND THE LIGHT EMITTING DIODES (LEDS) WERE ILLUMINATED. HOWEVER, AFTER THE START/CONTINUE BUTTON WAS PRESSED, THE AUTOPULSE INITIATED COMPRESSIONS THEN STOPPED AND DISPLAYED A USER ADVISORY (UA) 07 (DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE) MESSAGE. IT WAS ALSO REPORTED THAT A FULLY CHARGED BATTERY THAT WORKED WITH ANOTHER AUTOPULSE WAS IN USE WHEN THIS MESSAGE OCCURRED AND THE TRAINING LIFEBAND WAS PLACED IN THE CORRECT POSITION. THERE WAS NO REPORT OF ANY PATIENT INVOLVEMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 5151850 ↗
• MalfunctionSep 16, 2015Device Displays Incorrect Message

  IT WAS REPORTED THAT THE AUTOPULSE PLATFORM PERFORMED SOME COMPRESSIONS, THEN STOPPED AND IMMEDIATELY DISPLAYED A USER ADVISORY (UA) 07 (DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE) MESSAGE. THE CUSTOMER ATTEMPTED TO TROUBLESHOOT THE REPORTED PROBLEM BY TURNING THE SYSTEM ON AND OFF. THE AUTOPULSE PLATFORM ILLUMINATED THE GREEN LED PROVIDING AN INDICATION THAT IT WAS READY FOR USE. THE CUSTOMER DID NOT FIND ANYTHING WRONG WITH THE BATTERIES, CONTROL PANEL OR LED LIGHTS. THE CUSTOMER ENSURED THAT THE AUTOPULSE LIFEBAND WAS CORRECTLY INSTALLED AND TESTED THE AUTOPULSE WITH A MANNEQUIN AND THE SAME ISSUE OCCURRED. NO ADVERSE PATIENT SEQUELAE WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5082862 ↗

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