AutoPulse Battery 100 (REF 8700-0702-01)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00849111002042), received between Dec 22, 2015 and Aug 31, 2017 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Device Stops Intermittently” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionAug 31, 2017Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE AUTOPULSE BATTERY (SN UNK) WAS INSERTED IN THE AUTOPULSE PLATFORM (SN (B)(4)) AND THE USER HAD TO REPEATEDLY PRESS THE POWER BUTTON BEFORE THE PLATFORM WAS ABLE TO INITIALIZE. FOLLOWING THIS, THE PLATFORM PERFORMED CONTINUOUS COMPRESSION FOR AN UNSPECIFIED AMOUNT OF TIME; HOWEVER, EVENTUALLY POWERED OFF. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6836072 ↗
• MalfunctionMar 24, 2016Arcing; Battery Problem; Arcing; Battery Problem

  IT WAS REPORTED THAT THE AUTOPULSE NIMH BATTERY (S/N (B)(4)) ARCED TO A MEDICAL EMPLOYEE'S METAL BUTTON ON THEIR JACKET. THERE WAS NO REPORT OF INJURY TO A PERSON. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5522824 ↗
• MalfunctionMar 8, 2016Device Stops Intermittently; Visual Prompts will not Clear; Device Displays Incorrect Message; Device Stops Intermittently; Visual Prompts will not Clear; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING DEVICE CHECK THE AUTOPULSE PLATFORM (S/N (B)(4)) STOPPED COMPRESSIONS AFTER A FEW COMPRESSIONS DISPLAYING A "LOW BATTERY LEVEL" ERROR. THIS WAS WHILE USING A KNOWN FULLY CHARGE NIMH BATTERY (S/N (B)(4)). THE CUSTOMER TRIED TWO ADDITIONAL KNOWN FULLY CHARGED NIMH BATTERIES (S/N'S (B)(4)) WITH THE SAME RESULT. THERE WAS NO PATIENT INVOLVED WITH THIS EVENT. REFER TO MDRS 3010617000-2016-00143, 3010617000-2016-00144 AND 3010617000-2016-00145.

  Patient problems: No Patient Involvement

  MAUDE report 5487105 ↗
• MalfunctionMar 8, 2016Device Stops Intermittently; Visual Prompts will not Clear; Device Displays Incorrect Message; Device Stops Intermittently; Visual Prompts will not Clear; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING DEVICE CHECK THE AUTOPULSE PLATFORM (S/N (B)(4)) STOPPED COMPRESSIONS AFTER A FEW COMPRESSIONS DISPLAYING A "LOW BATTERY LEVEL" ERROR. THIS WAS WHILE USING A KNOWN FULLY CHARGE NIMH BATTERY (S/N (B)(4)). THE CUSTOMER TRIED TWO ADDITIONAL KNOWN FULLY CHARGED NIMH BATTERIES (S/N'S (B)(4)) WITH THE SAME RESULT. THERE WAS NO PATIENT INVOLVED WITH THIS EVENT. REFER TO MDRS 3010617000-2016-00143, 3010617000-2016-00144 AND 3010617000-2016-00171.

  Patient problems: No Patient Involvement

  MAUDE report 5487102 ↗
• MalfunctionMar 8, 2016Device Stops Intermittently; Visual Prompts will not Clear; Device Displays Incorrect Message; Device Stops Intermittently; Visual Prompts will not Clear; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING DEVICE CHECK THE AUTOPULSE PLATFORM (S/N (B)(4)) STOPPED COMPRESSIONS AFTER A FEW COMPRESSIONS DISPLAYING A "LOW BATTERY LEVEL" ERROR. THIS WAS WHILE USING A KNOWN FULLY CHARGE NIMH BATTERY (S/N (B)(4)). THE CUSTOMER TRIED TWO ADDITIONAL KNOWN FULLY CHARGED NIMH BATTERIES (S/N'S (B)(4)) WITH THE SAME RESULT. THERE WAS NO PATIENT INVOLVED WITH THIS EVENT. REFER TO MDRS 3010617000-2016-00143, 3010617000-2016-00145 AND 3010617000-2016-00171.

  Patient problems: No Patient Involvement

  MAUDE report 5487087 ↗
• MalfunctionJan 5, 2016Positioning Failure; Device Stops Intermittently; Positioning Failure; Device Stops Intermittently

  A CALL WAS DISPATCHED FOR AN (B)(6) FEMALE THAT WAS NOT BREATHING. UPON ARRIVAL, THE FIREFIGHTERS, PARAMEDIC AND ENGINEER WERE MET OUTSIDE BY THE RELATIVE WHO STATED THE PATIENT WAS NOT BREATHING. THE PATIENT WAS FOUND LYING ON THE FLOOR WITH A BYSTANDER MANUAL CPR IN PROGRESS (EXACT LENGTH OF TIME NOT PROVIDED). THE PATIENT HAD BEEN MOVED FROM THE BED TO THE FLOOR BY THE BYSTANDERS. THE PATIENT WAS NOT BREATHING, UNCONSCIOUS AND APPEARED TO BE IN CARDIAC ARREST. THE CREW OBTAINED INFORMATION FROM PATIENT'S BOYFRIEND WHO STATED THAT THE PATIENT WAS LAST SEE APPROXIMATELY 2 HOURS AGO AND WAS VOMITING THE NIGHT PRIOR AND HAD A HISTORY OF DIABETES. THE ABSENCE OF PULSE AND BREATHING WERE VERIFIED BY THE FIREFIGHTER. THE CREW MOVED THE PATIENT FROM BEDROOM FLOOR TO AN AREA IN THE BASEMENT WITH MORE ROOM FOR BETTER PATIENT ACCESS. MANUAL CPR WAS INITIATED AND IV ACCESS WAS OBTAINED IN THE RIGHT ANTE CUPITAL. AN ORAL AIRWAY ADJUNCT WAS ALSO PLACED BY ONE OF THE CREW. THE PATIENT WAS PLACED ON THE AUTOPULSE WITHOUT ANY ISSUES. HOWEVER, THE PLATFORM DISPLAYED "REALIGN PATIENT" MESSAGE. AFTER THE PATIENT WAS REALIGNED, THE PLATFORM WAS POWERED ON. THE LIFEBAND RETRACTED AND THE PLATFORM PE

  Patient problems: Not Applicable

  MAUDE report 5344129 ↗
• MalfunctionJan 5, 2016Positioning Failure; Device Stops Intermittently; Positioning Failure; Device Stops Intermittently

  A CALL WAS DISPATCHED FOR AN (B)(6) YEAR OLD FEMALE THAT WAS NOT BREATHING. UPON ARRIVAL, THE FIREFIGHTERS, PARAMEDIC AND ENGINEER WERE MET OUTSIDE BY THE RELATIVE WHO STATED THE PATIENT WAS NOT BREATHING. THE PATIENT WAS FOUND LYING ON THE FLOOR WITH A BYSTANDER MANUAL CPR IN PROGRESS (EXACT LENGTH OF TIME NOT PROVIDED). THE PATIENT HAD BEEN MOVED FROM THE BED TO THE FLOOR BY THE BYSTANDERS. THE PATIENT WAS NOT BREATHING, UNCONSCIOUS AND APPEARED TO BE IN CARDIAC ARREST. THE CREW OBTAINED INFORMATION FROM PATIENT'S BOYFRIEND WHO STATED THAT THE PATIENT WAS LAST SEE APPROXIMATELY 2 HOURS AGO AND WAS VOMITING THE NIGHT PRIOR AND HAD A HISTORY OF DIABETES. THE ABSENCE OF PULSE AND BREATHING WERE VERIFIED BY THE FIREFIGHTER. THE CREW MOVED THE PATIENT FROM BEDROOM FLOOR TO AN AREA IN THE BASEMENT WITH MORE ROOM FOR BETTER PATIENT ACCESS. MANUAL CPR WAS INITIATED AND IV ACCESS WAS OBTAINED IN THE RIGHT ANTE CUPITAL. AN ORAL AIRWAY ADJUNCT WAS ALSO PLACED BY ONE OF THE CREW. THE PATIENT WAS PLACED ON THE AUTOPULSE WITHOUT ANY ISSUES. HOWEVER, THE PLATFORM DISPLAYED "REALIGN PATIENT" MESSAGE. AFTER THE PATIENT WAS REALIGNED, THE PLATFORM WAS POWERED ON. THE LIFEBAND RETRACTED AND THE PLA

  Patient problems: Not Applicable

  MAUDE report 5344126 ↗
• MalfunctionJan 5, 2016Positioning Failure; Device Stops Intermittently; Positioning Failure; Device Stops Intermittently

  A CALL WAS DISPATCHED FOR AN (B)(6) OLD FEMALE THAT WAS NOT BREATHING. UPON ARRIVAL, THE FIREFIGHTERS, PARAMEDIC AND ENGINEER WERE MET OUTSIDE BY THE RELATIVE WHO STATED THE PATIENT WAS NOT BREATHING. THE PATIENT WAS FOUND LYING ON THE FLOOR WITH A BYSTANDER MANUAL CPR IN PROGRESS (EXACT LENGTH OF TIME NOT PROVIDED). THE PATIENT HAD BEEN MOVED FROM THE BED TO THE FLOOR BY THE BYSTANDERS. THE PATIENT WAS NOT BREATHING, UNCONSCIOUS AND APPEARED TO BE IN CARDIAC ARREST. THE CREW OBTAINED INFORMATION FROM PATIENT'S BOYFRIEND WHO STATED THAT THE PATIENT WAS LAST SEE APPROXIMATELY 2 HOURS AGO AND WAS VOMITING THE NIGHT PRIOR AND HAD A HISTORY OF DIABETES. THE ABSENCE OF PULSE AND BREATHING WERE VERIFIED BY THE FIREFIGHTER. THE CREW MOVED THE PATIENT FROM BEDROOM FLOOR TO AN AREA IN THE BASEMENT WITH MORE ROOM FOR BETTER PATIENT ACCESS. MANUAL CPR WAS INITIATED AND IV ACCESS WAS OBTAINED IN THE RIGHT ANTE CUPITAL. AN ORAL AIRWAY ADJUNCT WAS ALSO PLACED BY ONE OF THE CREW. THE PATIENT WAS PLACED ON THE AUTOPULSE WITHOUT ANY ISSUES. HOWEVER, THE PLATFORM DISPLAYED "REALIGN PATIENT" MESSAGE. AFTER THE PATIENT WAS REALIGNED, THE PLATFORM WAS POWERED ON. THE LIFEBAND RETRACTED AND THE PLATFORM

  Patient problems: Not Applicable

  MAUDE report 5344109 ↗
• MalfunctionDec 22, 2015Low Battery

  COMPLAINANT ALLEGED THAT WHEN THE NIMH BATTERY WAS PLACED INTO THE AUTOPULSE PLATFORM, THE DEVICE DISPLAYED USER ADVISORY ERROR CODES. THIS OCCURRED DURING A SHIFT CHECK. NO PATIENT INVOLVED. WHEN THE AUTOPULSE DEVICE WAS TESTED WITH ANOTHER BATTERY, USER ADVISORY ERROR MESSAGES DID NOT DISPLAY. THE NIMH BATTERY WAS PLACED IN THE CHARGER AND IT WOULD NOT FULLY CHARGE. THE BIOMED ENGINEER REPEATED THE BATTERY TO AUTOPULSE DEVICE TEST WHICH PRODUCED ERROR MESSAGES AGAIN. IT WAS DETERMINED BY THE BIOMED ENGINEER THAT THE AUTOPULSE WAS NOT DEFECTIVE, THE NIMH BATTERY WAS DEFECTIVE. NO ADDITIONAL INFORMATION WILL BE PROVIDED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 5321162 ↗

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