AutoPulse®Resuscitation System 100 (UDI 00849111065092)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00849111065092), received between Jan 12, 2017 and Jan 12, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Operational Issue” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionJan 12, 2017Device Operational Issue; Device Operational Issue

  IT WAS REPORTED THAT DURING A SHIFT CHECK, THE AUTO PULSE PLATFORM (S/N: (B)(4)) DISPLAYED 'SYSTEM ERROR' MESSAGE UPON POWERING ON. WHEN (B)(4) RECEIVED THE DEVICE ,THEY CONFIRMED SYSTEM ERROR MESSAGE. NO PATIENT INVOLVEMENT WAS PROVIDED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6248342 ↗

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