LIFEPAK CR Plus and LIFEPAK Express defibrillators 80427Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00883873823811), received between Apr 1, 2019 and Apr 1, 2019 — classified as 1 death.

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

1 other recall cover devices cleared under the same FDA submission (P160012); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• DeathApr 1, 2019Device Sensing Problem; Device Sensing Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT DURING A PATIENT EVENT THEIR DEVICE WAS UNABLE TO DETECT THE PATIENT THROUGH THE DEFIBRILLATION ELECTRODES. THE CUSTOMER ADVISED THAT ONE OF THEIR POLICE UNIT'S DEVICE KEPT REPEATING ITSELF, "PULL THE RED HANDLE AND ATTACH THE PADS AS DESCRIBED." THE CUSTOMER INDICATED THAT THE HANDLE HAD ALREADY BEEN PULLED AND THE DEFIBRILLATION ELECTRODES WERE ATTACHED TO THE PATIENT, AND THE ATTACHMENT WAS CHECKED. THE FIRE DEPARTMENT/EMS ARRIVED VERY SOON AFTER THE POLICE AND REMOVED THE CUSTOMER'S DEVICE AND ITS DEFIBRILLATION ELECTRODES AND CONNECTED THE PATIENT TO THEIR OWN DEFIBRILLATOR. AFTER THE EVENT THE CUSTOMER'S DEVICE DISPLAYED, "OK". EMS WAS ABLE TO GET A PULSE AT THE SCENE AFTER CPR, BUT THE PATIENT A (B)(6) YEAR OLD MALE WITH FAMILY HISTORY OF CARDIAC ARREST PASSED LATER AT THE HOSPITAL.

  Patient problems: Death

  MAUDE report 8471604 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P160012. One submission often covers many models, so check the product and lot details in each record.

• Z-1544-2026 · Jan 21, 2026 · Open, Classified
  PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes Catalog Numbers: 11101-000016 UDI-DI code: 00721902629013 Catalog Number: 11101-000017 UDI-DI code: 00721902682