AutoPulse Battery 100 (REF 8700-0702-03)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00849111065030), received between Sep 2, 2015 and Jun 17, 2016 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Battery 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2016Low Battery; Low Battery

  IT WAS REPORTED THAT DURING A SHIFT CHECK THE AUTOPULSE BATTERY (B)(4) SHOWED LOW BATTERY LEVEL WHILE BEING TESTED IN THE AUTOPULSE PLATFORM. HOWEVER THE AUTOPULSE BATTERY INDICATOR SHOWED "GREEN" LED (MEANING A FULL BATTERY). TO TROUBLESHOOT THE ISSUE THE PLATFORM WAS TESTED WITH OTHER BATTERIES WITHOUT ISSUE. THE BATTERY (B)(4) WAS RE-TESTED THE FOLLOWING DAY AND THE SAME PROBLEM OCCURRED.

  Patient problems: No Patient Involvement

  MAUDE report 5734231 ↗
• 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 5050546 ↗
• 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.

  Patient problems: No Patient Involvement

  MAUDE report 5050511 ↗
• 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 5050486 ↗

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