AutoPulse Li-ion Battery™ 100 (REF 8700-0752-08)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00849111001847), received between Nov 7, 2017 and Oct 1, 2024 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (10 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 1, 2024Failure to Eject; Failure to Eject

  THE CUSTOMER REPORTED THAT THE AUTOPULSE LI-ION BATTERY (SN UNKNOWN) IS STUCK AND CANNOT BE REMOVED FROM THE AUTOPULSE PLATFORM (SN (B)(6). NO FURTHER INFORMATION WAS PROVIDED. IT IS UNKNOWN WHEN THE PROBLEM OCCURRED. HOWEVER, PATIENT USE INFORMATION WAS REQUESTED BUT NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 20348755 ↗
• MalfunctionSep 11, 2021Battery Problem; Battery Problem

  THE PATIENT WAS UNDERWATER FOR OVER 30 MINUTES BEFORE THE RESUSCITATION ATTEMPT. THE CREW DEPLOYED THE AUTOPULSE PLATFORM (SN (B)(4)) FOR RESUSCITATING THE PATIENT. THE CUSTOMER REPORTED THAT THE AUTOPULSE PLATFORM DID NOT POWER ON USING AUTOPULSE LI-ION BATTERIES (SN (B)(4), (B)(4), AND (B)(4)). PER THE CUSTOMER, THE PATIENT DIED, AND THE OUTCOME WAS NOT RELATED TO THE AUTOPULSE DEVICE. THE CUSTOMER PROVIDED NO FURTHER INFORMATION. AFTER THE PATIENT EVENT, THE DISTRIBUTOR WAS UNABLE TO DUPLICATE THE CUSTOMER-REPORTED COMPLAINT. THE AUTOPULSE PLATFORM AND THE LI-ION BATTERIES USED DURING THE PATIENT EVENT WERE WORKED AS INTENDED. PLEASE SEE THE FOLLOWING RELATED MFR REPORT: MFR #3010617000-2021-00816 FOR THE AUTOPULSE PLATFORM (SN (B)(4)). MFR #3010617000-2021-00874 FOR THE 1ST AUTOPULSE LI-ION BATTERY (SN (B)(4)). MFR #3010617000-2021-00876 FOR THE 3RD AUTOPULSE LI-ION BATTERY (SN (B)(4)).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12457751 ↗
• MalfunctionSep 11, 2021Battery Problem; Battery Problem

  THE PATIENT WAS UNDERWATER FOR OVER 30 MINUTES BEFORE THE RESUSCITATION ATTEMPT. THE CREW DEPLOYED THE AUTOPULSE PLATFORM (SN (B)(4)) FOR RESUSCITATING THE PATIENT. THE CUSTOMER REPORTED THAT THE AUTOPULSE PLATFORM DID NOT POWER ON USING AUTOPULSE LI-ION BATTERIES (SN (B)(4). PER THE CUSTOMER, THE PATIENT DIED, AND THE OUTCOME WAS NOT RELATED TO THE AUTOPULSE DEVICE. THE CUSTOMER PROVIDED NO FURTHER INFORMATION. AFTER THE PATIENT EVENT, THE DISTRIBUTOR WAS UNABLE TO DUPLICATE THE CUSTOMER-REPORTED COMPLAINT. THE AUTOPULSE PLATFORM AND THE LI-ION BATTERIES USED DURING THE PATIENT EVENT WERE WORKED AS INTENDED. PLEASE SEE THE FOLLOWING RELATED MFR REPORT: MFR #3010617000-2021-00816 FOR THE AUTOPULSE PLATFORM (SN (B)(4)). MFR #3010617000-2021-00874 FOR THE 1ST AUTOPULSE LI-ION BATTERY (SN (B)(4)). MFR #3010617000-2021-00875 FOR THE 2ND AUTOPULSE LI-ION BATTERY (SN (B)(4)).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12457749 ↗
• MalfunctionSep 11, 2021Battery Problem; Battery Problem

  THE PATIENT WAS UNDERWATER FOR OVER 30 MINUTES BEFORE THE RESUSCITATION ATTEMPT. THE CREW DEPLOYED THE AUTOPULSE PLATFORM (SN (B)(4)) FOR RESUSCITATING THE PATIENT. THE CUSTOMER REPORTED THAT THE AUTOPULSE PLATFORM DID NOT POWER ON USING AUTOPULSE LI-ION BATTERIES (SN (B)(4)). PER THE CUSTOMER, THE PATIENT DIED, AND THE OUTCOME WAS NOT RELATED TO THE AUTOPULSE DEVICE. THE CUSTOMER PROVIDED NO FURTHER INFORMATION. AFTER THE PATIENT EVENT, THE DISTRIBUTOR WAS UNABLE TO DUPLICATE THE CUSTOMER-REPORTED COMPLAINT. THE AUTOPULSE PLATFORM AND THE LI-ION BATTERIES USED DURING THE PATIENT EVENT WERE WORKED AS INTENDED. PLEASE SEE THE FOLLOWING RELATED MFR REPORT: MFR #3010617000-2021-00816 FOR THE AUTOPULSE PLATFORM (SN (B)(4)). MFR #3010617000-2021-00875 FOR THE 2ND AUTOPULSE LI-ION BATTERY (SN (B)(4)). MFR #3010617000-2021-00876 FOR THE 3RD AUTOPULSE LI-ION BATTERY (SN (B)(4)).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12457748 ↗
• MalfunctionFeb 6, 2021Battery Problem; Battery Problem

  DURING THE PATIENT USE, THE AUTOPULSE PLATFORM (SN (B)(4)) STOPPED PERFORMING COMPRESSIONS AND POWERED OFF BY ITSELF. THERE WERE NO USER ADVISORIES DISPLAYED ON THE PLATFORM. THE MANUAL CPR WAS PERFORMED DURING THE TROUBLESHOOTING. NO CONSEQUENCES OR IMPACT TO PATIENT. THE USER OBSERVED THE AUTOPULSE LI-ION BATTERY (SN (B)(4)) STATUS AS FLASHING GREEN LIGHTS BEFORE IT WAS PLACED INTO THE PLATFORM. THE PLATFORM WAS TESTED LATER ON WITH A GOOD KNOWN BATTERY AND FUNCTIONED APPROPRIATELY AND AS INTENDED. THE BATTERY (SN (B)(4)) WAS PLACED IN ANOTHER PLATFORM AND THE REPORTED ISSUE WAS DUPLICATED. THE BATTERY WAS MANUFACTURED ON 7/27/2016 AND IS MORE THAN 4 YEARS OLD. ZOLL RECOMMENDS THE REPLACEMENT OF BATTERIES THAT HAVE EXCEEDED THEIR EXPECTED SERVICE LIFE OF 3 YEARS. PLEASE SEE THE FOLLOWING RELATED MFR REPORTS: MFR 3010617000-2021-00080 FOR AUTOPULSE PLATFORM (SN (B)(4)).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11290324 ↗
• MalfunctionDec 6, 2019Battery Problem; Battery Problem

  DURING PATIENT USE, THE AUTOPULSE LI-ION BATTERY WITH SERIAL NUMBER SN: (B)(4) WAS INSERTED INTO THE AUTOPULSE PLATFORM (SN: (B)(4) TO PERFORM COMPRESSIONS. HOWEVER, AFTER PERFORMING COMPRESSIONS FOR 10 MINUTES, THE PLATFORM STOPPED COMPRESSIONS AND DISPLAYED "REPLACE BATTERY" MESSAGE. THE BATTERY WAS REPLACED WITH THE SECOND AUTOPULSE LI-ION BATTERY (SN: (B)(4)). PER CUSTOMER, THE SECOND BATTERY HAD NO CHARGE PRIOR TO USING IT IN THE AUTOPULSE PLATFORM. THE THERAPY WAS INTERRUPTED AFTER 2 MINUTES WITH THE PLATFORM DISPLAYING "LOW BATTERY" ERROR. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT WAS REPORTED. PLEASE SEE THE FOLLOWING RELATED MFR REPORTS: MFR # 3010617000-2019-01103 FOR THE AUTOPULSE PLATFORM SN: (B)(4). MFR # 3010617000-2019-01122 FOR THE AUTOPULSE LI-ION BATTERY SN: (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9434427 ↗
• MalfunctionDec 6, 2019Battery Problem; Battery Problem

  DURING PATIENT USE, THE AUTOPULSE LI-ION BATTERY WITH SERIAL NUMBER SN: (B)(4) WAS INSERTED INTO THE AUTOPULSE PLATFORM (SN: (B)(4)) TO PERFORM COMPRESSIONS. HOWEVER, AFTER PERFORMING COMPRESSIONS FOR 10 MINUTES, THE PLATFORM STOPPED COMPRESSIONS AND DISPLAYED "REPLACE BATTERY" MESSAGE. THE BATTERY WAS REPLACED WITH THE SECOND AUTOPULSE LI-ION BATTERY (SN: (B)(4)). PER CUSTOMER, THE SECOND BATTERY HAD NO CHARGE PRIOR TO USING IT IN THE AUTOPULSE PLATFORM. THE THERAPY WAS INTERRUPTED AFTER 2 MINUTES WITH THE PLATFORM DISPLAYING "LOW BATTERY" ERROR. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT WAS REPORTED. PLEASE SEE THE FOLLOWING RELATED MFR REPORTS: MFR # 3010617000-2019-01103 FOR THE AUTOPULSE PLATFORM SN: (B)(4). MFR # 3010617000-2019-01124 FOR THE AUTOPULSE LI-ION BATTERY SN: (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9434425 ↗
• MalfunctionMar 29, 2018Low Battery; Battery Problem; Low Battery; Battery Problem

  DURING ROUTINE TESTING, A FULLY CHARGED (FOUR GREEN LED) AUTOPULSE LI-ION BATTERY (SN (B)(4)) WAS INSERTED INTO THE AUTOPULSE PLATFORM AND DISPLAYED A "REPLACE BATTERY" MESSAGE. THE USER FURTHER TESTED THE BATTERY IN THE AUTOPULSE MULTI-CHEMISTRY CHARGER (MCC), AND BATTERY CHARGING WAS UNSUCCESSFUL. THE PLATFORM WAS TESTED AND OPERATED AS EXPECTED WITH NO ISSUE. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 7382959 ↗
• MalfunctionMar 29, 2018Battery Problem; Battery Problem

  DURING ROUTINE TESTING, A FULLY CHARGED (FOUR GREEN LED) AUTOPULSE LI-ION BATTERY ((B)(4)) WAS INSERTED INTO THE AUTOPULSE PLATFORM AND DISPLAYED A "REPLACE BATTERY" MESSAGE. THE USER FURTHER TESTED THE BATTERY IN THE AUTOPULSE MULTI-CHEMISTRY CHARGER (MCC), AND WAS UNABLE TO SUCCESSFULLY CHARGE. THE PLATFORM WAS TESTED USING ANOTHER BATTERY AND OPERATED WITH NO ISSUE. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 7382954 ↗
• MalfunctionNov 8, 2017Battery Problem; Device Operates Differently Than Expected; Battery Problem; Device Operates Differently Than Expected

  AS REPORTED, THE USER INSERTED A FULLY CHARGED (FOUR GREEN LEDS DISPLAYED ON THE BATTERY STATUS INDICATOR) AUTOPULSE LI-ION BATTERY (B)(4) IN AN AUTOPULSE PLATFORM, AND THE PLATFORM DISPLAYED A "REPLACE BATTERY" MESSAGE. THE BATTERY, PRIOR TO PLATFORM INSERTION, WAS CHECKED AND THE BATTERY STATUS INDICATOR DISPLAYED FOUR GREEN LEDS (FULLY CHARGED). THE ISSUE WAS OBSERVED DURING ROUTINE CHECK AND NO PATIENT WAS INVOLVED. IT WAS FURTHER REPORTED THAT FOLLOWING THE EVENT, THE USER TESTED THE BATTERY BY CHARGING IT IN AN AUTOPULSE MULTI CHEMISTRY CHARGER AND THE BATTERY WAS UNABLE TO CHARGE. THE USER STATED THAT THEY MAINTAIN A REGULAR BATTERY ROTATION. ADDITIONALLY, THE PLATFORM WAS ALSO TESTED BY INSERTING ANOTHER AUTOPULSE LI-ION BATTERY AND OPERATED AS INTENDED WITHOUT ANY FAULT OBSERVED.

  Patient problems: No Patient Involvement

  MAUDE report 7009515 ↗
• MalfunctionNov 8, 2017Battery Problem; Device Operates Differently Than Expected; Battery Problem; Device Operates Differently Than Expected

  AS REPORTED, THE USER INSERTED A FULLY CHARGED AUTOPULSE LI-ION BATTERY (SN (B)(4)) IN AN AUTOPULSE PLATFORM (SN UNK), AND THE PLATFORM DISPLAYED A "REPLACE BATTERY" MESSAGE. THE BATTERY, PRIOR TO PLATFORM INSERTION, WAS CHECKED AND THE BATTERY STATUS INDICATOR DISPLAYED FOUR GREEN LEDS (FULLY CHARGED). THE ISSUE WAS OBSERVED DURING ROUTINE CHECK AND NO PATIENT WAS INVOLVED. THE USER FURTHER TESTED THE BATTERY BY CHARGING IT IN THE AUTOPULSE MULTI CHEMISTRY CHARGER AND THE BATTERY WAS UNABLE TO CHARGE. THIS REFERENCES THE REPORT OF THE BATTERY NOT HOLDING CHARGE. THE REPORT OF THE PLATFORM DISPLAYING A "REPLACE BATTERY" MESSAGE IS REFERENCED UNDER MFR 3010617000-2017-00889.

  Patient problems: No Patient Involvement

  MAUDE report 7009502 ↗
• MalfunctionNov 7, 2017Low Battery; Device Operates Differently Than Expected; Low Battery; Device Operates Differently Than Expected

  AS REPORTED DURING DEVICE CHECK, THE LI-ION BATTERY (SN: (B)(4)) WAS INDICATING FOUR GREEN LEDS WHEN THE STATUS BUTTON WAS PRESSED; HOWEVER, WHEN THE BATTERY WAS INSERTED INTO THE AUTOPULSE PLATFORM, IT WAS DISPLAYING AN ERROR MESSAGE "REPLACE BATTERY/CHARGE". WHEN THE BATTERY WAS INSERTED INTO THE MULTI-CHEMISTRY CHARGER (MCC), IT WAS INDICATING FAIL (RED) LED. THE BATTERY WAS LAST CHARGED SUCCESSFULLY ON (B)(6) 2017. THE CUSTOMER FOLLOWS THREE BATTERY ROTATION AS RECOMMENDED BY ZOLL. THE PLATFORM USED IS WORKING AS INTENDED FOR USE WITH OTHER LI-ION BATTERIES. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 7008408 ↗

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