LIFEPAK CR Plus and LIFEPAK Express defibrillators 99403 (REF 99403-000001)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00883873823927), received between Jun 19, 2019 and Nov 1, 2023 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Power Problem” (4 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 1, 2023Power Problem; Power Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WAS SHOWING ALL THREE ICONS (ATTENTION, CHARGE-PAK AND SERVICE WRENCH). WITH ALL THREE ICONS ILLUMINATED, THE DEVICE MAY NOT HAVE SUFFICIENT POWER AVAILABLE TO DELIVER EFFECTIVE DEFIBRILLATION THERAPY TO A PATIENT, IF NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18047340 ↗
• MalfunctionAug 4, 2022Power Problem; Power Problem

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WAS SHOWING ALL THREE ICONS (ATTENTION, CHARGE-PAK AND SERVICE WRENCH). WITH ALL THREE ICONS ILLUMINATED, THE DEVICE MAY NOT HAVE SUFFICIENT POWER AVAILABLE TO DELIVER EFFECTIVE DEFIBRILLATION THERAPY TO A PATIENT, IF IT WAS NEEDED. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15168090 ↗
• MalfunctionDec 23, 2019Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WAS NOT ALWAYS TURNING ON WHEN THE COVER WAS OPENED. IN THIS STATE THE DEVICE WOULD BE INOPERABLE AND DEFIBRILLATION THERAPY WOULD NOT BE AVAILABLE IF NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9512170 ↗
• MalfunctionOct 3, 2019Failure to Power Up; Power Problem; Failure to Power Up; Power Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THE DEVICE WAS SHOWING TWO ICONS (ATTENTION AND CHARGE-PAK). THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT. UPON EVALUATION OF THE CUSTOMER'S DEVICE, PHYSIO OBSERVED THAT THE DEVICE WAS SHOWING ALL THREE ICONS (ATTENTION, CHARGE-PAK AND SERVICE WRENCH). WITH ALL THREE ICONS ILLUMINATED, THE DEVICE MAY NOT HAVE SUFFICIENT POWER AVAILABLE TO DELIVER EFFECTIVE DEFIBRILLATION THERAPY TO A PATIENT, IF IT WAS NEEDED. ADDITIONALLY, THE DEVICE WOULD NOT POWER ON WHEN PROMPTED, WHICH WOULD ALSO CAUSE THE DEVICE TO BE UNABLE TO DELIVER DEFIBRILLATION THERAPY TO A PATIENT, IF IT WAS NEEDED.

  Patient problems: No Patient Involvement

  MAUDE report 9154069 ↗
• MalfunctionSep 6, 2019Power Problem; Power Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WAS SHOWING ALL THREE ICONS (ATTENTION, CHARGE-PAK AND SERVICE WRENCH). WITH ALL THREE ICONS ILLUMINATED, THE DEVICE MAY NOT HAVE SUFFICIENT POWER AVAILABLE TO DELIVER EFFECTIVE DEFIBRILLATION THERAPY TO A PATIENT, IF IT WAS NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8970725 ↗
• MalfunctionJun 19, 2019Audible Prompt/Feedback Problem; Audible Prompt/Feedback Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE DID NOT PROVIDE ANY VOICE PROMPTS WHEN THE DEVICE WAS POWERED ON. WITHOUT VOICE PROMPTS, A LAY USER WOULD NOT RECEIVE THE AUDIBLE INSTRUCTIONS ON HOW TO PROPERLY USE THE DEVICE ON A PATIENT. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8714563 ↗

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