AutoPulse Battery 100 (UDI 00849111002059)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00849111002059), received between Feb 3, 2017 and Feb 3, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Battery Problem” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2017Battery Problem; Battery Problem

  DURING A SHIFT CHECK, IT WAS REPORTED THAT THE AUTOPULSE PLATFORM DISPLAYED A MESSAGE OF "REPLACE/RECHARGE BATTERY; EMPTY BATTERY SYMBOL" AFTER A FULLY CHARGED AUTOPULSE LITHIUM ION BATTERY (B)(4) WAS INSERTED. THE REPORTER INDICATED THAT THE BATTERY HAD 4 GREEN LEDS LIT. ACCORDING TO THE REPORTER, THE ISSUE WAS REPLICATED SEVERAL TIMES WITH MULTIPLE PLATFORMS.

  Patient problems: No Patient Involvement

  MAUDE report 6302039 ↗

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