LIFEPAK® CR Plus and LIFEPAK Express defibrillators 99403 (REF 99403-000156)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00885074440323), received between Mar 28, 2018 and Oct 22, 2018 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Failure to Power Up” (7 reports).

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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 22, 2018Failure to Power Up; No Audible Prompt/Feedback; Failure to Power Up; No Audible Prompt/Feedback

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE HAD ALL THREE ICONS (CHARGE PAK, ATTENTION AND SERVICE WRENCH) PRESENT ON ITS READINESS DISPLAY, AND WHEN ATTEMPTING TO POWER THE DEVICE ON THERE WERE NO VOICE PROMPTS. WITHOUT VOICE PROMPTS, A DEVICE USER WOULD NOT RECEIVE THE AUDIBLE INSTRUCTIONS ON HOW TO PROPERLY USE THE DEVICE ON A PATIENT WHICH COULD DELAY, OR PREVENT, DEFIBRILLATION IF NECESSARY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7990582 ↗
• MalfunctionAug 29, 2018Failure to Power Up; Failure to Power Up

  A 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 7827006 ↗
• MalfunctionAug 22, 2018Power Problem; Power Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE HAD ALL THREE ICONS (CHARGE PAK, ATTENTION AND SERVICE WRENCH) PRESENT ON ITS READINESS DISPLAY. THE CUSTOMER ADVISED THAT THE DEVICE DID NOT PROVIDE ANY VOICE PROMPTS WHEN THE DEVICE WAS POWERED ON. THE THREE ICONS BEING ILLUMINATED INDICATES THAT THE DEVICE MAY NOT BE ABLE TO PROVIDE SUFFICIENT DEFIBRILLATION THERAPY, IF NECESSARY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7806197 ↗
• MalfunctionJul 30, 2018Failure to Analyze Signal; Failure to Analyze Signal

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE HAD A SERVICE WRENCH ICON ON ITS READINESS DISPLAY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT. UPON EVALUATION OF THE CUSTOMER¿S DEVICE, PHYSIO-CONTROL FOUND THAT THE DEVICE DOES NOT RECOGNIZE A SHOCKABLE RHYTHM AND DOES NOT CHARGE AND SHOCK. AS A RESULT, DEFIBRILLATION WOULD NOT BE POSSIBLE IF IT WERE NECESSARY.

  Patient problems: No Patient Involvement

  MAUDE report 7732369 ↗
• MalfunctionJul 13, 2018Unintended Power Up; Unintended Power Up

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WAS POWERING ITSELF ON WITHOUT ANY USER INTERACTION AND IT WOULD HAVE TO BE MANUALLY POWERED OFF. AS A RESULT, THE DEVICE'S INTERNAL BATTERIES MAY BECOME PREMATURELY DEPLETED AND THE DEVICE MAY NOT HAVE ENOUGH POWER TO PROVIDE ADEQUATE DEFIBRILLATION THERAPY IF NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7687357 ↗
• MalfunctionJul 9, 2018Incorrect Interpretation of Signal; Incorrect Interpretation of Signal

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE HAD A SERVICE WRENCH PRESENT ON ITS READINESS INDICATOR. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT. UPON EVALUATION OF THE CUSTOMER'S DEVICE, PHYSIO-CONTROL OBSERVED THAT IT WOULD BEHAVE AS THOUGH A PATIENT LOAD WAS BEING DETECTED WHEN NO TEST LOAD WAS ACTUALLY CONNECTED. ADDITIONALLY, WHEN A PROPER TEST LOAD WAS CONNECTED TO THE DEVICE IT WOULD INCORRECTLY ADVISE THAT THE LEADS WERE OFF. BASED ON THIS BEHAVIOR, PHYSIO-CONTROL DETERMINED THAT THE DEVICE IS INCAPABLE OF PROPERLY DETECTING A PATIENT LOAD AND THEREFORE WOULD BE UNABLE TO CHARGE AND SHOCK IF IT WERE NECESSARY.

  Patient problems: No Patient Involvement

  MAUDE report 7672236 ↗
• MalfunctionJun 22, 2018Failure to Power Up; Device Displays Incorrect Message; Failure to Power Up; Device Displays Incorrect Message

  A CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WAS SHOWING ALL THREE ICONS (ATTENTION, CHARGE-PAK AND SERVICE WRENCH) AND WILL NOT POWER ON. 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 7630977 ↗
• MalfunctionJun 15, 2018Failure to Deliver Energy; Failure to Deliver Energy

  PHYSIO-CONTROL WAS PERFORMING PREVENTATIVE MAINTENANCE ON A CUSTOMER'S DEVICE AND OBSERVED THAT THE DEVICE WOULD NOT DELIVER DEFIBRILLATION ENERGY. AS A RESULT, DEFIBRILLATION THERAPY WOULD NOT BE POSSIBLE, IF IT WAS NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7606573 ↗
• MalfunctionJun 13, 2018Power Problem; Power Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE HAD ALL THREE ICONS (CHARGE PAK, ATTENTION AND SERVICE WRENCH) PRESENT ON ITS READINESS DISPLAY. THE THREE ICONS BEING ILLUMINATED INDICATES THAT THE DEVICE MAY NOT BE ABLE TO PROVIDE SUFFICIENT DEFIBRILLATION THERAPY, IF NECESSARY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7597207 ↗
• MalfunctionJun 11, 2018Connection Problem; Connection Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT DURING A PATIENT EVENT, THEIR DEVICE WOULD NOT DETECT THAT A PATIENT WAS CONNECTED. THE DEVICE GAVE A "CONNECT ELECTRODES" MESSAGE EVEN THOUGH THE PATIENT WAS CONNECTED TO THE DEVICE. MEDICAL PERSONNEL REMOVED THE ELECTRODES FROM THE DEVICE AND PLACED THEM INTO A BACKUP DEVICE WHEN EMS ARRIVED ON SCENE. THERE WAS NO ADVERSE EFFECTS TO THE (B)(6) YEAR OLD PATIENT AS A RESULT OF THE REPORTED ISSUE AS THE BACKUP DEVICE WAS USED TO CONTINUE PATIENT CARE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7589261 ↗
• MalfunctionJun 8, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  A 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 7584751 ↗
• MalfunctionMay 22, 2018Failure to Power Up; Device Displays Incorrect Message; Failure to Power Up; Device Displays Incorrect Message

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WAS SHOWING ALL THREE ICONS (ATTENTION, CHARGE-PAK AND SERVICE WRENCH) AND THEIR DEVICE WILL NOT POWER ON. 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 7533044 ↗
• MalfunctionMay 8, 2018Power 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 7495348 ↗
• MalfunctionApr 24, 2018Failure to Charge; Failure to Deliver Energy; Failure to Charge; Failure to Deliver Energy

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT A NON-CRITICAL ISSUE WITH THEIR DEVICE RELATED TO THE SERVICE WRENCH APPEARING ON THE READINESS DISPLAY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT. UPON EVALUATION OF THE CUSTOMER'S DEVICE, PHYSIO-CONTROL OBSERVED THAT THEIR DEVICE WOULD NOT CHARGE AND SHOCK. AS A RESULT, DEFIBRILLATION ENERGY WOULD NOT BE DELIVERED, IF IT WERE NECESSARY.

  Patient problems: No Patient Involvement

  MAUDE report 7455563 ↗
• MalfunctionApr 20, 2018Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THE DEVICE LATCH BROKE OFF ON THE LID AND DID NOT ALLOW THE LATCH TO CLOSE. THE DEVICE WOULD NOT POWER ON. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 7448473 ↗
• MalfunctionMar 28, 2018Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THE SWITCH ON THEIR DEVICE WAS DAMAGED AND WAS KEEPING THE DEVICE'S CHARGE-PAK FROM GOING IN AND OUT. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT. UPON EVALUATION OF THE CUSTOMER'S DEVICE, PHYSIO-CONTROL OBSERVED THAT THE ON/OFF LID LATCH WAS MISSING AND THE DEVICE COULD NOT BE POWERED ON.

  Patient problems: No Patient Involvement

  MAUDE report 7380522 ↗
• MalfunctionMar 28, 2018Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE DISPLAYED ALL THREE ICONS (CHARGE-PAK, ATTENTION, AND SERVICE WRENCH) AND WOULD NO LONGER POWER ON. THE CUSTOMER ALSO ADVISED THAT THEIR DEVICE PERIODICALLY MAKES A ¿RATTLING NOISE¿. THE CUSTOMER ADVISED THAT THE CHARGE-PAK INSTALLED IN THEIR DEVICE HAD A LOT CODE OF 1616 AND EXPIRATION DATE OF (B)(4) 2019. THERE WAS NO PATIENT USE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7379253 ↗