AutoPulse Li-ion Battery™ 100 (REF 8700-0752-03)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00849111065054), received between Sep 2, 2015 and Feb 20, 2023 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (12 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2023Battery Problem; Battery Problem

  THE CUSTOMER REPORTED THAT THE FULLY CHARGED AUTOPULSE LI-ION BATTERY (SN (B)(4)) DIDN'T POWER UP THE AUTOPULSE PLATFORM. NO FURTHER INFORMATION WAS PROVIDED. THE AUTOPULSE PLATFORM POWERED UP PROPERLY WITH ANOTHER AUTOPULSE LI-ION BATTERY. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16406242 ↗
• MalfunctionJun 30, 2022Battery Problem; Battery Problem

  THE AUTOPULSE PLATFORM STOPPED WORKING DURING SHIFT CHECK WITH THE AUTOPULSE LI-ION BATTERY (SN UNKNOWN). THE CUSTOMER REPLACED THE BATTERY WITH ANOTHER ONE, AND THE PLATFORM WORKED WITHOUT PROBLEMS. AFTERWARD, THE CUSTOMER CHARGED THE REPORTED DEFECTIVE BATTERY, BUT THE BATTERY WAS UNABLE TO BE CHARGED SUCCESSFULLY. THE CUSTOMER PROVIDED NO FURTHER INFORMATION. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14876779 ↗
• MalfunctionOct 18, 2020Battery Problem; Battery Problem

  AS REPORTED, THE AUTO-PULSE PLATFORM (SN (B)(4)) WAS USED TO TREAT A (B)(6)-YEAR-OLD MALE PATIENT IN CARDIOPULMONARY ARREST WHO WAS FOUND ON A STREET BY THE FIREFIGHTER. THE PATIENT HAD A HEART BYPASS HISTORY. THE FIREFIGHTER PERFORMED MANUAL CPR FOR 18 MINUTES UNTIL THE AMBULANCE ARRIVED. AFTER THE PARAMEDIC ARRIVED, THE AED WAS ATTACHED TO THE PATIENT. THE PATIENT'S RHYTHM SHOWED VENTRICULAR FIBRILLATION (VF), AND THE DEVICE DELIVERED A SHOCK. THEN, MANUAL CPR HAS PERFORMED AGAIN. THE PATIENT WAS PLACED ON THE AUTO-PULSE PLATFORM. THE PATIENT'S RHYTHM INDICATED ASYSTOLE AT THAT TIME. THE PLATFORM PERFORMED COMPRESSIONS FOR APPROXIMATELY 4 MINUTES AND UNEXPECTEDLY POWERED OFF. PER THE PARAMEDIC, IT IS UNKNOWN WHETHER THE PLATFORM DISPLAYED ANY MESSAGE ON THE CONTROL PANEL. THE CREW PRESSED THE POWER BUTTON, AND THE AP POWERED UP. AFTER THE "INITIALIZING" MESSAGE WAS DISPLAYED ON THE SCREEN, THE USER PRESSED THE RESTART BUTTON TO RESTART COMPRESSION. ABOUT 2 MINUTES LATER, THE AP POWERED OFF AGAIN. THE PLATFORM WAS RESTARTED IMMEDIATELY AND THE COMPRESSIONS WERE PERFORMED FOR ABOUT ONE MINUTE, THEN THE PLATFORM POWERED OFF AGAIN. THE MANUAL CPR WAS IMMEDIATELY PERFORMED ON THE PATI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10695084 ↗
• MalfunctionOct 18, 2020Battery Problem; Battery Problem

  AS REPORTED, THE AUTOPULSE PLATFORM (SN (B)(4)) WAS USED TO TREAT A (B)(6)-YEAR-OLD MALE PATIENT IN CARDIOPULMONARY ARREST WHO WAS FOUND ON A STREET BY THE FIREFIGHTER. THE PATIENT HAD A HEART BYPASS HISTORY. THE FIREFIGHTER PERFORMED MANUAL CPR FOR 18 MINUTES UNTIL THE AMBULANCE ARRIVED. AFTER THE PARAMEDIC ARRIVED, THE AED WAS ATTACHED TO THE PATIENT. THE PATIENT'S RHYTHM SHOWED VENTRICULAR FIBRILLATION (VF), AND THE DEVICE DELIVERED A SHOCK. THEN, MANUAL CPR HAS PERFORMED AGAIN. THE PATIENT WAS PLACED ON THE AUTOPULSE PLATFORM. THE PATIENT'S RHYTHM INDICATED ASYSTOLE AT THAT TIME. THE PLATFORM PERFORMED COMPRESSIONS FOR APPROXIMATELY 4 MINUTES, AND UNEXPECTEDLY, POWERED OFF. PER THE PARAMEDIC, IT IS UNKNOWN WHETHER THE PLATFORM DISPLAYED ANY MESSAGE ON THE CONTROL PANEL. THE CREW PRESSED THE POWER BUTTON, AND THE AP POWERED UP. AFTER THE "INITIALIZING" MESSAGE WAS DISPLAYED ON THE SCREEN, THE USER PRESSED THE RESTART BUTTON TO RESTART COMPRESSION. ABOUT 2 MINUTES LATER, THE AP POWERED OFF AGAIN. THE PLATFORM WAS RESTARTED IMMEDIATELY AND THE COMPRESSIONS WERE PERFORMED FOR ABOUT ONE MINUTE, THEN THE PLATFORM POWERED OFF AGAIN. THE MANUAL CPR WAS IMMEDIATELY PERFORMED ON THE PATI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10695083 ↗
• MalfunctionNov 8, 2019Battery Problem; Battery Problem

  DURING SHIFT CHECK, THE AUTOPULSE LI-ION BATTERY (SN: (B)(4)) WAS SUCCESSFULLY CHARGED IN A MULTI CHEMISTRY CHARGER (MCC) WITH 4 GREEN LED SHOWN ON THE BATTERY. HOWEVER, THE CUSTOMER NOTED THE BATTERY STATUS INDICATOR ON AN AUTOPULSE PLATFORM SHOWED NO BATTERY POWER. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9298889 ↗
• MalfunctionDec 12, 2018Use of Device Problem; Use of Device Problem

  AS REPORTED, THE AUTOPULSE PLATFORM ((B)(4)) WAS USED TO TREAT AN (B)(6) YEAR OLD FEMALE PATIENT WITH CARDIOPULMONARY ARREST. THE PLATFORM PERFORMED COMPRESSIONS FOR A WHILE AND SUDDENLY POWERED OFF. THE CUSTOMER CHANGED THE BATTERY AND THE PLATFORM WAS POWERED ON SUCCESSFULLY. AFTER PERFORMING COMPRESSIONS FOR AN UNSPECIFIED AMOUNT OF TIME, THE AUTOPULSE PLATFORM POWERED OFF AGAIN AND THE PLATFORM WOULDN'T POWER ON. THE PATIENT WAS GIVEN MANUAL CPR FOR 30 MINUTES. HOWEVER, ROSC WAS NOT ACHIEVED AND THE PATIENT WAS PRONOUNCED DEAD AT THE HOSPITAL. DURING EVALUATION OF THE AUTOPULSE PLATFORM ON (B)(6) 2018, THE THIRD LI-ION BATTERY SN (B)(4) WAS FOUND TO BE INVOLOVED IN THE REPORTED EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8155956 ↗
• MalfunctionNov 8, 2018Loss of Power; Failure to Power Up; Loss of Power; Failure to Power Up

  AS REPORTED, THE AUTOPULSE PLATFORM WAS USED TO TREAT AN (B)(6) YEAR OLD FEMALE PATIENT WITH CARDIOPULMONARY ARREST. THE PLATFORM PERFORMED COMPRESSIONS FOR A WHILE AND SUDDENLY POWERED OFF. THE CUSTOMER CHANGED THE BATTERY AND THE PLATFORM WAS POWERED ON SUCCESSFULLY. AFTER PERFORMING COMPRESSIONS FOR AN UNSPECIFIED AMOUNT OF TIME, THE AUTOPULSE PLATFORM POWERED OFF AGAIN AND THE PLATFORM WOULDN'T POWER ON. THE PATIENT WAS GIVEN MANUAL CPR FOR 30 MINUTES. HOWEVER, ROSC WAS NOT ACHIEVED AND THE PATIENT WAS PRONOUNCED DEAD AT THE HOSPITAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8053844 ↗
• MalfunctionNov 8, 2018Loss of Power; Failure to Power Up; Loss of Power; Failure to Power Up

  AS REPORTED, THE AUTOPULSE PLATFORM WAS USED TO TREAT AN (B)(6) FEMALE PATIENT WITH CARDIOPULMONARY ARREST. THE PLATFORM PERFORMED COMPRESSIONS FOR A WHILE AND SUDDENLY POWERED OFF. THE CUSTOMER CHANGED THE BATTERY AND THE PLATFORM WAS POWERED ON SUCCESSFULLY. AFTER PERFORMING COMPRESSIONS FOR AN UNSPECIFIED AMOUNT OF TIME, THE AUTOPULSE PLATFORM POWERED OFF AGAIN AND THE PLATFORM WOULDN'T POWER ON. THE PATIENT WAS GIVEN MANUAL CPR FOR 30 MINUTES. HOWEVER, ROSC WAS NOT ACHIEVED AND THE PATIENT WAS PRONOUNCED DEAD AT THE HOSPITAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8053842 ↗
• MalfunctionSep 28, 2018Battery Problem; Battery Problem

  THE CUSTOMER INDICATED THE AUTOPULSE LITHIUM-ION BATTERY STATUS INDICATOR DISPLAYED FULL CAPACITY; HOWEVER, THE BATTERY DOES NOT POWER ON THE AUTOPULSE PLATFORM DURING SHIFT CHECK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7920145 ↗
• MalfunctionJun 6, 2017Failure to Power Up; Battery Problem; Failure to Power Up; Battery Problem

  IT WAS REPORTED THAT A FULLY CHARGED AUTOPULSE LITHIUM ION BATTERY (B)(4) DID NOT POWER ON THE AUTOPULSE PLATFORM DURING A SHIFT CHECK. THE PLATFORM DID POWER ON WHEN OTHER AUTOPULSE BATTERIES WERE USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 6615483 ↗
• MalfunctionMay 19, 2016Low Battery; Battery Problem; Low Battery; Battery Problem

  THE CUSTOMER REPORTED THAT DURING DAILY SHIFT CHECK, WHEN THEY PLACED A KNOWN FULLY CHARGED BATTERY INTO THE AUTOPULSE, THE PLATFORM DISPLAYED "REPLACE BATTERY" MESSAGE UPON POWER-UP. THE CUSTOMER DID NOT SEE ANY USER ADVISORY CODES. THEY ONLY SAW "EMPTY BATTERY" ICON ON THE DISPLAY. THE CUSTOMER KNEW THESE WERE FULLY CHARGED BECAUSE THEIR MCC INDICATED GREEN LED (FULLY CHARGED) ON THE DISPLAY. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 5668875 ↗
• MalfunctionMay 19, 2016Low Battery; Battery Problem; Low Battery; Battery Problem

  THE CUSTOMER REPORTED THAT DURING DAILY SHIFT CHECK, WHEN THEY PLACED A KNOWN FULLY CHARGED BATTERY INTO THE AUTOPULSE, THE PLATFORM DISPLAYED "REPLACE BATTERY" MESSAGE UPON POWER-UP. THE CUSTOMER DID NOT SEE ANY USER ADVISORY CODES. THEY ONLY SAW "EMPTY BATTERY" ICON ON THE DISPLAY. THE CUSTOMER KNEW THESE WERE FULLY CHARGED BECAUSE THEIR MCC INDICATED GREEN LED (FULLY CHARGED) ON THE DISPLAY. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 5668874 ↗
• MalfunctionNov 19, 2015Battery Problem

  IT WAS REPORTED DURING A DEVICE CHECK, THAT THE BATTERY CAPACITY REDUCED SOONER THAN IT SHOULD. THE BATTERY CHARGE STATUS INDICATOR REDUCED AFTER 3 DAYS OF NO USE. THERE WAS NO REPORT OF ANY PATIENT INVOLVEMENT. NO ADDITIONAL DETAILS WERE PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 5237400 ↗
• MalfunctionNov 5, 2015Battery Problem

  IT WAS REPORTED DURING A DEVICE CHECK, THAT THE BATTERY CAPACITY REDUCED SOONER THAN IT SHOULD. THE BATTERY CHARGE STATUS INDICATOR REDUCED AFTER 3 DAYS OF NO USE. THERE WAS NO REPORT OF ANY PATIENT INVOLVEMENT. NO ADDITIONAL DETAILS WERE PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 5206116 ↗
• MalfunctionSep 2, 2015Battery Problem

  IT WAS REPORTED THAT DURING A TRAINING, THE AUTOPULSE PLATFORM SHUT DOWN IMMEDIATELY AFTER COMPRESSIONS WERE INITIATED. WHEN THE AUTOPULSE PLATFORM WAS USED WITH THE CUSTOMER'S THREE NIMH BATTERIES AND ONE LI-ION BATTERY, THE SAME ISSUES OCCURRED. THERE WERE NO REPORTS OF ANY PATIENT INVOLVEMENT. NO FURTHER DETAILS WERE PROVIDED. PLEASE NOTE THAT THE DATE OF EVENTS WERE NOT PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 5050576 ↗

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