AutoPulse Li-ion Battery™ 100 (REF 8700-0752-11)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00849111001878), received between Oct 5, 2022 and Oct 5, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 5, 2022Battery Problem; Battery Problem

  THE CUSTOMER REPORTED THAT DURING THE SHIFT CHECK, THE AUTOPULSE PLATFORM (SN (B)(4)) DID NOT POWER UP USING THE FULLY CHARGED AUTOPULSE LI-ION BATTERIES (SN (B)(4)). THE CUSTOMER STATED THAT THE BATTERY WAS FULLY CHARGED BEFORE USING IT WITH THE AUTOPULSE PLATFORM, AND THE CUSTOMER COULD NOT PROVIDE INFORMATION ON THE STATUS LEDS. THE CUSTOMER STATED THAT THEY DID NOT HAVE ANOTHER LI-ION BATTERY TO TEST THE AUTOPULSE PLATFORM. IN ADDITION, THE CUSTOMER REPORTED A BROKEN HEAD RESTRAINT ON THE AUTOPULSE PLATFORM. NO PATIENT INVOLVEMENT. PLEASE SEE THE FOLLOWING RELATED MFR REPORT: MFR 3010617000-2022-01708 FOR THE AUTOPULSE PLATFORM. MFR 3010617000-2022-01856 FOR THE AUTOPULSE LI-ION BATTERY (SN (B)(4))

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15545758 ↗
• MalfunctionOct 5, 2022Battery Problem; Battery Problem

  THE CUSTOMER REPORTED THAT DURING THE SHIFT CHECK, THE AUTOPULSE PLATFORM (SN: (B)(4) DID NOT POWER UP USING THE FULLY CHARGED AUTOPULSE LI-ION BATTERIES (SN: (B)(4) AND (B)(4). THE CUSTOMER STATED THAT THE BATTERY WAS FULLY CHARGED BEFORE USING IT WITH THE AUTOPULSE PLATFORM, AND THE CUSTOMER COULD NOT PROVIDE INFORMATION ON THE STATUS LEDS. THE CUSTOMER STATED THAT THEY DID NOT HAVE ANOTHER LI-ION BATTERY TO TEST THE AUTOPULSE PLATFORM. IN ADDITION, THE CUSTOMER REPORTED A BROKEN HEAD RESTRAINT ON THE AUTOPULSE PLATFORM. NO PATIENT INVOLVEMENT. PLEASE SEE THE FOLLOWING RELATED MFR REPORT: MFR 3010617000-2022-01708 FOR THE AUTOPULSE PLATFORM. MFR 3010617000-2022-01755 FOR THE AUTOPULSE LI-ION BATTERY (SN: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15545749 ↗

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