AutoPulse Li-ion Battery™ 100 (REF 8700-0752-01)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,151 adverse event reports that list this exact device (DI 00849111001823), received between Sep 2, 2015 and Sep 11, 2026 — classified as 1,151 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (1,038 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 25 most recent of 1,151 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026Battery Problem

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50744570 ↗
• MalfunctionJan 21, 2026Difficult to Remove

  THE CUSTOMER REPORTED THE AUTOPULSE LI-ION BATTERY (SN (B)(6) GETS STUCK INSIDE THE AUTOPULSE PLATFORM AND IT IS HARD TO USE THIS BATTERY ON A MOMENT'S NOTICE. THE CUSTOMER WAS ABLE TO REMOVE THE BATTERY FROM THE PLATFORM. NO PHYSICAL DAMAGE WAS NOTED. THIS WAS NOTICED DURING CHECKOUT. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24140555 ↗
• MalfunctionJan 5, 2026Battery Problem

  DURING THE SHIFT CHECK, THE AUTOPULSE LI-ION BATTERY (SN (B)(6) WAS OBSERVED TO BE SWOLLEN, WHICH MADE INSERTION INTO THE AUTOPULSE PLATFORM DIFFICULT. THE CHARGER SHOWED A CHARGED/READY STATUS WITH NO FAILURE INDICATED AFTER THE CHARGE ATTEMPT. WHEN THE BATTERY STATUS BUTTON WAS PRESSED, THE GREEN LEDS LIT, CONFIRMING A FULL CHARGE. THE PLATFORM WAS CONFIRMED TO BE FUNCTIONAL WHEN USED WITH ANOTHER BATTERY. NO PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 23954679 ↗
• MalfunctionMar 13, 2025Battery Problem; Battery Problem

  DURING A CALL, THE FIRST AUTOPULSE LI-ION BATTERY (SN UNKNOWN) COMPLETELY DISCHARGED WITHIN 30 SECONDS OF USE. THIS BATTERY IS NORMALLY STORED IN THE AUTOPULSE PLATFORM AND LEFT PARTIALLY EJECTED. THE CHARGER AND BATTERIES ARE TYPICALLY LEFT ON THE AMBULANCE CONNECTED TO SHORELINE POWER FOR CHARGING. THE CUSTOMER BELIEVES EVERYTHING WAS FUNCTIONING CORRECTLY BEFORE THE AMBULANCE WAS DISCONNECTED FROM SHORELINE POWER AND THAT THE SECOND BATTERY (SN UNKNOWN) AND THIRD BATTERY (SN UNKNOWN) WERE COMPLETELY NON-FUNCTIONAL SHORTLY AFTER DEPARTURE, DESPITE THE CLOSE DISTANCE TO THE CALL. NO FURTHER INFORMATION WAS PROVIDED. THE PATIENT'S STATUS INFORMATION WAS REQUESTED BUT THE CUSTOMER DID NOT PROVIDE A RESPONSE.

  Patient problems: Insufficient Information

  MAUDE report 21601834 ↗
• MalfunctionMar 13, 2025Battery Problem; Battery Problem

  DURING A CALL, THE FIRST AUTOPULSE LI-ION BATTERY COMPLETELY DISCHARGED WITHIN 30 SECONDS OF USE. THIS BATTERY IS NORMALLY STORED IN THE AUTOPULSE PLATFORM AND LEFT PARTIALLY EJECTED. THE CHARGER AND BATTERIES ARE TYPICALLY LEFT ON THE AMBULANCE CONNECTED TO SHORELINE POWER FOR CHARGING. THE CUSTOMER BELIEVES EVERYTHING WAS FUNCTIONING CORRECTLY BEFORE THE AMBULANCE WAS DISCONNECTED FROM SHORELINE POWER AND THAT THE SECOND BATTERY AND THIRD BATTERY WERE COMPLETELY NON-FUNCTIONAL SHORTLY AFTER DEPARTURE, DESPITE THE CLOSE DISTANCE TO THE CALL. NO FURTHER INFORMATION WAS PROVIDED. THE PATIENT'S STATUS INFORMATION WAS REQUESTED BUT THE CUSTOMER DID NOT PROVIDE A RESPONSE.

  Patient problems: Insufficient Information

  MAUDE report 21601832 ↗
• MalfunctionMar 13, 2025Battery Problem; Battery Problem

  DURING A CALL, THE FIRST AUTOPULSE LI-ION BATTERY (SN UNKNOWN) COMPLETELY DISCHARGED WITHIN 30 SECONDS OF USE. THIS BATTERY IS NORMALLY STORED IN THE AUTOPULSE PLATFORM AND LEFT PARTIALLY EJECTED. THE CHARGER AND BATTERIES ARE TYPICALLY LEFT ON THE AMBULANCE CONNECTED TO SHORELINE POWER FOR CHARGING. THE CUSTOMER BELIEVES EVERYTHING WAS FUNCTIONING CORRECTLY BEFORE THE AMBULANCE WAS DISCONNECTED FROM SHORELINE POWER AND THAT THE SECOND BATTERY (SN UNKNOWN) AND THIRD BATTERY (SN UNKNOWN) WERE COMPLETELY NON-FUNCTIONAL SHORTLY AFTER DEPARTURE, DESPITE THE CLOSE DISTANCE TO THE CALL. NO FURTHER INFORMATION WAS PROVIDED. THE PATIENT'S STATUS INFORMATION WAS REQUESTED BUT THE CUSTOMER DID NOT PROVIDE A RESPONSE.

  Patient problems: Insufficient Information

  MAUDE report 21601831 ↗
• MalfunctionFeb 12, 2025Battery Problem; Battery Problem

  AS REPORTED, THE AUTOPULSE PLATFORM (SN (B)(6) FAILED DURING A CARDIAC ARREST. PER THE REPORTER, THE DEVICE DID NOT DISPLAY ANY USER ADVISORIES BEFORE IT STOPPED DELIVERING COMPRESSIONS. ACCORDING TO THE CREW, THE AUTOPULSE PLATFORM JUST SHUT OFF AFTER AROUND 6 MINUTES WHEN WAS USED WITH THE AUTOPULSE LI-ION BATTERY (SN (B)(6). PER THE CUSTOMER, THE BATTERY WAS FULLY CHARGED BEFORE USE DURING THE PATIENT EVENT. A SECOND FULLY CHARGED AUTOPULSE LI-ION BATTERY (SN UNKNOWN) WAS INSTALLED BUT THE DEVICE STILL FAILED TO DELIVER COMPRESSIONS. THE PATIENT WAS ON THE LIVING ROOM FLOOR; THE TYPE AND CONDITION OF THE FLOORING SURFACE WERE NOT SPECIFIED. IN ADDITION, IT WAS NOTED THAT THE LIFEBAND WAS RUBBING THE PLASTIC ENCLOSURE OF THE PLATFORM AND CAUSING DAMAGE TO THE LIFEBAND AS WELL. MANUAL CPR WAS CONTINUED UNTIL THE CREW DEPLOYED A SECOND AUTOPULSE PLATFORM (SN UNKNOWN). HOWEVER, IT FAILED AS WELL DUE TO A LIFEBAND ALIGNMENT ISSUE THAT COULD NOT BE RESOLVED. THE CREW DID MANUAL CPR THROUGHOUT THE REST OF THE EVENT. NO IMPACT OR CONSEQUENCE TO THE PATIENT.. AFTER THE CALL, BACK AT THE STATION, THE SECOND PLATFORM (SN UNKNOWN) WAS TESTED AFTER THE DRIVESHAFT WAS REALIGNED AND THE DEVICE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21370838 ↗
• MalfunctionFeb 12, 2025Battery Problem; Battery Problem

  AS REPORTED, THE AUTOPULSE PLATFORM (SN(B)(6) FAILED DURING A CARDIAC ARREST. PER THE REPORTER, THE DEVICE DID NOT DISPLAY ANY USER ADVISORIES BEFORE IT STOPPED DELIVERING COMPRESSIONS. ACCORDING TO THE CREW, THE AUTOPULSE PLATFORM JUST SHUT OFF AFTER AROUND 6 MINUTES WHEN WAS USED WITH THE AUTOPULSE LI-ION BATTERY (SN (B)(6). PER THE CUSTOMER, THE BATTERY WAS FULLY CHARGED BEFORE USE DURING THE PATIENT EVENT. A SECOND FULLY CHARGED AUTOPULSE LI-ION BATTERY (SN UNKNOWN) WAS INSTALLED BUT THE DEVICE STILL FAILED TO DELIVER COMPRESSIONS. THE PATIENT WAS ON THE LIVING ROOM FLOOR; THE TYPE AND CONDITION OF THE FLOORING SURFACE WERE NOT SPECIFIED. IN ADDITION, IT WAS NOTED THAT THE LIFEBAND WAS RUBBING THE PLASTIC ENCLOSURE OF THE PLATFORM AND CAUSING DAMAGE TO THE LIFEBAND AS WELL. MANUAL CPR WAS CONTINUED UNTIL THE CREW DEPLOYED A SECOND AUTOPULSE PLATFORM (SN UNKNOWN). HOWEVER, IT FAILED AS WELL DUE TO A LIFEBAND ALIGNMENT ISSUE THAT COULD NOT BE RESOLVED. THE CREW DID MANUAL CPR THROUGHOUT THE REST OF THE EVENT. NO IMPACT OR CONSEQUENCE TO THE PATIENT. AFTER THE CALL, BACK AT THE STATION, THE SECOND PLATFORM (SN UNKNOWN) WAS TESTED AFTER THE DRIVESHAFT WAS REALIGNED AND THE DEVICE F

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21370651 ↗
• MalfunctionFeb 3, 2025Battery Problem; Battery Problem

  WHILE ATTEMPTING TO RESUSCITATE A CARDIAC ARREST PATIENT WITH THE AUTOPULSE PLATFORM USING THE AUTOPULSE LI-ION BATTERY (SN (B)(6), THE DEVICE STOPPED COMPRESSING AFTER ONE OR TWO MINUTES AND DISPLAYED A BATTERY SYMBOL. THE CREW REPLACED THE BATTERY AND RESUMED OPERATION. ACCORDING TO THE CREW, THE BATTERY (SN (B)(6) INDICATED FOUR SOLID GREEN LIGHTS THEN AND CONTINUES TO DO SO. NO ADDITIONAL INFORMATION WAS GIVEN. THE PATIENT'S STATUS INFORMATION WAS REQUESTED, BUT THE CUSTOMER DID NOT RESPOND.

  Patient problems: Insufficient Information

  MAUDE report 21294607 ↗
• MalfunctionJan 29, 2025Battery Problem; Battery Problem

  THE CUSTOMER REPORTED AUTOPULSE LI-ION BATTERY (SN (B)(6) FAILED AFTER 15 MINUTES OF USE ON A FULL ARREST PATIENT EVENT. THE 71-YEAR-OLD MALE PATIENT WAS NORMAL SIZED AND WEIGHED 75KG. THE CUSTOMER NOTICED THAT THE BATTERY WAS SHOWING 3 YELLOW LEDS ON THE BATTERY METER, VERSUS NORMAL GREEN BARS, AFTER IT STOPPED WORKING. THE CUSTOMER'S BATTERIES ARE ON A DAILY ROTATION AND THE BATTERY WAS FULLY CHARGED PRIOR TO USE. MANUAL CPR WAS CONTINUED FOR APPROXIMATELY 2 MINUTES UNTIL THE SPARE BATTERY WAS BROUGHT IN FROM THE AMBULANCE. THE PATIENT WAS IN ASYSTOLE PRIOR TO THE BATTERY FAILURE AND REMAINED IN ASYSTOLE AFTER THE BATTERY WAS SWITCHED OUT. THE PLATFORM WAS TESTED USING A MANIKIN AFTER THE CALL AND IT IS PERFORMING AS INTENDED. THE CUSTOMER DOES NOT BELIEVE THE FAILURE AFFECTED THE OVERALL PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21267093 ↗
• MalfunctionJan 8, 2025Battery Problem; Battery Problem

  THE CUSTOMER REPORTED THAT, DURING SHIFT CHECK, THE FULLY CHARGED AUTOPULSE LI-ION BATTERY (SN (B)(6) DOES NOT POWER UP THE AUTOPULSE PLATFORM. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21105465 ↗
• MalfunctionJan 6, 2025Battery Problem; Battery Problem

  DURING THE SHIFT CHECK, THE AUTOPULSE LI-ION BATTERY (SN (B)(6) STATUS LEDS DISPLAYED 4 FLASHING GREEN LIGHTS AFTER IT WAS REMOVED FROM THE MULTI-CHEMISTRY BATTERY CHARGER (MCC). HOWEVER, THE BATTERY WAS UNABLE TO POWER ON THE AUTOPULSE PLATFORM. WHILE THE LED INDICATOR STATUS ON THE CHARGER AFTER THE CHARGING ATTEMPT IS UNKNOWN, THE SAME ISSUE PERSISTED WHEN THE BATTERY WAS TESTED WITH A DIFFERENT CHARGER. THE AUTOPULSE PLATFORM WAS TESTED WITH ANOTHER BATTERY AND FUNCTIONED AS INTENDED. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21077456 ↗
• MalfunctionJan 5, 2025Battery Problem; Battery Problem

  THE CUSTOMER REPORTED THE AUTOPULSE LI-ION BATTERY (SN (B)(6) IS UNABLE TO CHARGE IN THE MULTI-CHEMISTRY BATTERY CHARGER (MCC). HOWEVER, BASED ON ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER ON 12/10/2024, THE AUTOPULSE PLATFORM FAILED DURING THE PATIENT CALL WHEN THE BATTERY (SN (B)(6) WAS USED. THE USER SWITCHED TO THE SECOND BATTERY TO CONTINUE THE RESUSCITATION. THE PATIENT'S STATUS INFORMATION WAS REQUESTED, BUT THE CUSTOMER DID NOT PROVIDE A RESPONSE. PER THE REPORTER, THE BATTERY WAS ABLE TO CHARGE IN MULTIPLE CHARGERS, AND ALTERNATIVELY, THE CHARGER COULD CHARGE OTHER BATTERIES.

  Patient problems: Insufficient Information

  MAUDE report 21075862 ↗
• MalfunctionOct 16, 2024Battery Problem; Battery Problem

  THE CUSTOMER REPORTED DURING SHIFT CHECK, THE AUTOPULSE LI-ION BATTERY (SN (B)(6) WILL NOT CHARGE AND IS NO LONGER POWERING ON THE AUTOPULSE PLATFORM. ACCORDING TO THE CUSTOMER, THE BATTERY WAS PULLED OFF THE MULTI-CHEMISTRY BATTERY CHARGER (MCC) BUT DID NOT POWER ON THE PLATFORM. THE COLOR OF THE STATUS LEDS ON THE BATTERY AND CHARGER PRIOR TO USE IN THE PLATFORM ARE UNKNOWN. AFTER THE ATTEMPTED USE IN THE PLATFORM, THE STATUS LEDS ON THE BATTERY SHOWED ONE ORANGE LED. THE BATTERY WAS TESTED IN A DIFFERENT MCC BUT IT WAS STILL UNABLE TO CHARGE. THE MCC IS ABLE TO SUCCESSFULLY CHARGE OTHER BATTERIES. IT IS UNKNOWN THE LAST TIME THE BATTERY WAS SUCCESSFULLY CHARGED. THE PLATFORM IS PERFORMING AS INTENDED WITH OTHER BATTERIES. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20467791 ↗
• MalfunctionOct 11, 2024Battery Problem; Battery Problem

  THE CUSTOMER REPORTED THE AUTOPULSE LI-ION BATTERY (B)(6) DOESN`T POWER ON AN AUTOPULSE PLATFORM, CHARGE, OR RECONDITION. NO ADDITIONAL 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 20434263 ↗
• MalfunctionOct 2, 2024Battery Problem; Battery Problem

  DURING SHIFT CHECK, THE FULLY CHARGED AUTOPULSE LI-ION BATTERY (SN (B)(6)) FAILED TO POWER UP THE AUTOPULSE PLATFORM. PER THE CUSTOMER, THE AUTOPULSE MULTI-CHEMISTRY BATTERY CHARGER SHOWED THAT THE BATTERY WAS FULL AND HAD COMPLETED CHARGING. THE BATTERY'S STATUS LEDS WERE FLASHING GREEN, INDICATING THAT IT HAD EXCEEDED THREE YEARS OF USE FROM THE DATE OF MANUFACTURE; HOWEVER, IT IS FULLY CHARGED. PER THE CUSTOMER, THE AUTOPULSE PLATFORM POWERS UP AND FUNCTIONS AS INTENDED USING OTHER LI-ION BATTERIES. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20354893 ↗
• MalfunctionSep 3, 2024Difficult to Remove; Difficult to Remove

  THE CUSTOMER REPORTED DIFFICULTY REMOVING THE AUTOPULSE LI-ION BATTERY (SN B)(6)) FROM THE PLATFORM AND CHARGERS. IT IS UNKNOWN WHEN THE PROBLEM OCCURRED. HOWEVER, PATIENT USE INFORMATION WAS REQUESTED BUT NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20131289 ↗
• MalfunctionAug 26, 2024Battery Problem; Battery Problem

  DURING SHIFT CHECK, THE FULLY CHARGED (SHOWING FOUR GREEN LIGHTS) AUTOPULSE LI-ION BATTERY (SN (B)(6) DID NOT POWER ON THE AUTOPULSE PLATFORM. AFTER CHARGING THE BATTERY, THE CHARGER SHOWED A GREEN LED (READY SYMBOL), AND THE BATTERY WAS FULLY CHARGED. NO PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20072698 ↗
• MalfunctionAug 7, 2024Battery Problem; Battery Problem

  DURING PATIENT USE, THE CUSTOMER REPORTED THE AUTOPULSE PLATFORM SN (B)(6) POWERED OFF AFTER 10 SECONDS WHEN THE BATTERY SN (B)(6) WAS USED. THE CREW WAS NOT SURE IF ANY WARNING MESSAGES WERE DISPLAYED. THE CREW IMMEDIATELY SWITCHED TO MANUAL CPR. FOLLOWING THE INSERTION OF THE SECOND BATTERY IN THE AUTOPULSE PLATFORM, THE DEVICE CONTINUED COMPRESSIONS WITHOUT ANY ISSUES. NO CONSEQUENCES OR IMPACT TO PATIENT. AFTER THE CALL, THE FIRST BATTERY SN (B)(6) WAS TESTED, SHOWING GREEN BLINKING LIGHTS WHEN THE STATUS BUTTON WAS PRESSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19935502 ↗
• MalfunctionJul 12, 2024Battery Problem; Battery Problem

  THE CUSTOMER REPORTED THAT THE AUTOPULSE PLATFORM (SN (B)(6)) OVERHEATED DURING THE PATIENT CALL. THE AREA WHERE THE LIFEBAND CONNECTED BECAME VERY HOT AND THERE WAS A BURNING SMELL. IN ADDITION, THE AUTOPULSE LI-ION BATTERY (SN (B)(6)) DEPLETED FAST DURING THIS INCIDENT. PER THE REPORTER, THE PLATFORM WAS ON THE BLACK EMS TRAP, PLACED ON THE STRETCHER DURING THE INCIDENT AND THE STRETCHER NEEDED TO BE STATIONARY TO START COMPRESSIONS. THE PATIENT WAS OVER 6 FEET TALL AND AROUND 300 LBS. THE CUSTOMER DID NOT OBSERVE ANY ABNORMALITIES WITH THE LIFEBAND BAND DURING THE USE. THE BATTERY IS CHANGED EVERY 24 HOURS WITH A 3-BATTERY ROTATION SCHEDULE. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19736352 ↗
• MalfunctionJul 12, 2024Battery Problem; Battery Problem

  DURING A CPR CALL, THE FULLY CHARGED AUTOPULSE LI-ION BATTERIES (SN (B)(6)) WOULD NOT POWER ON THE AUTOPULSE PLATFORM. THE BATTERIES SHOWED AS FULLY CHARGED ON THE MULTI-CHEMISTRY BATTERY CHARGER BEFORE USE IN THE PLATFORM. MANUAL CPR WAS PERFORMED. THE PATIENT DID NOT SURVIVE. PER THE CUSTOMER, THE USE OF AUTOPULSE PLATFORM WOULDN'T HAVE CHANGED THE PATIENT'S OUTCOME. THE PLATFORM IS PERFORMING AS INTENDED USING KNOWN GOOD BATTERIES AND THE BATTERY ISSUE WAS REPLICATED IN THE STATION AFTER THE CALL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19727454 ↗
• MalfunctionJul 12, 2024Battery Problem; Battery Problem

  DURING A CPR CALL, THE FULLY CHARGED AUTOPULSE LI-ION BATTERIES SN (B)(6) AND (B)(6) WOULD NOT POWER ON THE AUTOPULSE PLATFORM. THE BATTERIES SHOWED AS FULLY CHARGED ON THE MULTI-CHEMISTRY BATTERY CHARGER BEFORE USE IN THE PLATFORM. MANUAL CPR WAS PERFORMED. THE PATIENT DID NOT SURVIVE. PER THE CUSTOMER, THE USE OF AUTOPULSE PLATFORM WOULDN'T HAVE CHANGED THE PATIENT'S OUTCOME. THE PLATFORM IS PERFORMING AS INTENDED USING KNOWN GOOD BATTERIES AND THE BATTERY ISSUE WAS REPLICATED IN THE STATION AFTER THE CALL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19727452 ↗
• MalfunctionJun 12, 2024Battery Problem; Battery Problem

  THE CUSTOMER REPORTED THAT THE AUTOPULSE LI-ION BATTERY (SN (B)(6)) STOPPED WORKING DURING THE RESUSCITATION ATTEMPT. UPON PRESSING THE BATTERY'S STATUS INDICATOR, FOUR LEDS FLASHED, INDICATING THAT THE BATTERY HAD EXCEEDED THREE YEARS OF USE FROM THE DATE OF MANUFACTURE. THE BATTERY WAS MANUFACTURED IN (B)(6)2019 AND IS OVER FOUR YEARS OLD. PER THE CUSTOMER, THE BATTERY FAILURE DID NOT AFFECT PATIENT CARE, AND MANUAL CPR WAS PERFORMED FOR THE REST OF THE CALL. THERE WERE NO CONSEQUENCES OR IMPACTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19521144 ↗
• MalfunctionMay 24, 2024Battery Problem; Battery Problem

  THE CUSTOMER ADVISED THAT DURING SHIFT CHECK, THE LED LIGHTS ON THE MULTI-CHEMISTRY BATTERY CHARGER (MCC) WERE GREEN, INDICATING THE AUTOPULSE LI-ION BATTERY (SN (B)(6)) IS FULLY CHARGED. WHEN THE BATTERY IS TAKEN OUT OF THE CHARGER AND THE TEST BUTTON WAS PRESSED AND ALL FOUR LEDS BLINK GREEN 6 TIMES AND THEN GO OUT. HOWEVER, THE BATTERY WILL NOT POWER THE AUTOPULSE PLATFORM. THE PLATFORM PERFORMS AS INTENDED WITH OTHER BATTERIES. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19397445 ↗
• MalfunctionApr 3, 2024Difficult to Remove; Difficult to Remove

  THE CUSTOMER REPORTED THAT THE AUTOPULSE LI-ION BATTERY (SN UNKNOWN) IS STUCK IN 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 19038839 ↗

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