LIFEPAK® CR Plus and LIFEPAK Express defibrillators 99403 (REF 99403-000157)Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00885074440330), received between Mar 26, 2018 and Mar 5, 2020 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Failure to Power Up” (4 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 5, 2020Failure to Analyze Signal; Failure to Analyze Signal

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT A NON-CRITICAL ISSUE WITH THEIR DEVICE. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT. UPON EVALUATION OF THE CUSTOMER'S DEVICE, PHYSIO-CONTROL OBSERVED THAT THE DEVICE LOGGED A CRITICAL ERROR CODE THAT MAY RESULT IN DEFIBRILLATION THERAPY BEING UNAVAILABLE, IF IT IS NEEDED.

  Patient problems: No Patient Involvement

  MAUDE report 9794046 ↗
• MalfunctionOct 23, 2018Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  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 7996641 ↗
• MalfunctionSep 28, 2018Power Problem; Power Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE HAD DISPLAYED A PREMATURE LOW-BATTERY INDICATOR. THERE WERE NO REPORTS OF PATIENT USE ASSOCIATED WITH THE REPORTED ISSUE. UPON EVALUATION OF THE DEVICE, PHYSIO-CONTROL OBSERVED THAT THE INTERNAL HYBRID LAYER CAPACITOR (HLC) BATTERIES HAD DEPLETED, WHICH COULD INHIBIT THE DEVICE'S ABILITY TO PROVIDE DEFIBRILLATION THERAPY, IF NECESSARY.

  Patient problems: No Patient Involvement

  MAUDE report 7918616 ↗
• MalfunctionSep 24, 2018Failure to Power Up; Failure to Power Up

  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 7903854 ↗
• MalfunctionAug 20, 2018No Audible Prompt/Feedback; No Audible Prompt/Feedback

  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 7798092 ↗
• MalfunctionAug 8, 2018Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  THE CUSTOMER INITIALLY REPORTED THAT THEIR DEVICE WAS SHOWING ITS SERVICE WRENCH. AFTER FURTHER INVESTIGATION INTO THE REPORTED ISSUE, IT WAS OBSERVED THAT THERE WAS AN ISSUE WITH THE DEVICE THAT CAN CAUSE THE ECG SIGNAL TO BE A FLAT LINE AND THE DEVICE WOULD NOT BE ABLE TO RECOGNIZE A SHOCKABLE ECG RHYTHM AS A RESULT. THERE WAS NO PATIENT USE ASSOCIATED.

  Patient problems: No Patient Involvement

  MAUDE report 7762685 ↗
• MalfunctionJul 27, 2018Failure to Analyze Signal; Failure to Analyze Signal

  PHYSIO-CONTROL WAS PERFORMING PREVENTATIVE MAINTENANCE ON A CUSTOMER'S DEVICE AND OBSERVED AN EVENT CODE LOGGED IN THE DEVICE'S MEMORY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT. UPON FURTHER EVALUATION OF THE CUSTOMER'S DEVICE, PHYSIO-CONTROL OBSERVED THAT THE DEVICE WAS NOT ABLE TO RECOGNIZE A SHOCKABLE RHYTHM. AS A RESULT, DEFIBRILLATION THERAPY WOULD NOT BE AVAILABLE, IF IT WAS NEEDED.

  Patient problems: No Patient Involvement

  MAUDE report 7728218 ↗
• MalfunctionJul 17, 2018Failure to Power Up; Failure to Power Up

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

  Patient problems: No Patient Involvement

  MAUDE report 7696372 ↗
• MalfunctionJul 16, 2018Failure to Power Up; Failure to Power Up

  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 WOULD NOT POWER ON WHEN PROMPTED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7692550 ↗
• MalfunctionJul 16, 2018Power Problem; Power Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE DISPLAYED ALL THREE ICONS (CHARGE-PAK, ATTENTION, AND SERVICE WRENCH). THE ILLUMINATION OF ALL THREE ICONS INDICATES THAT THE DEVICE MAY NOT BE ABLE TO PROVIDE SUFFICIENT DEFIBRILLATION THERAPY, IF NECESSARY. THERE WAS NO PATIENT USE REPORTED FOR THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7692421 ↗
• MalfunctionJul 13, 2018Power Problem; Power Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE DISPLAYED ALL THREE ICONS (CHARGE-PAK, ATTENTION, AND SERVICE WRENCH). THE ILLUMINATION OF ALL THREE ICONS INDICATES THAT THE DEVICE MAY NOT BE ABLE TO PROVIDE SUFFICIENT DEFIBRILLATION THERAPY, IF NECESSARY. THERE WAS NO PATIENT USE REPORTED FOR THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7688031 ↗
• MalfunctionJul 13, 2018No Audible Prompt/Feedback; No Audible Prompt/Feedback

  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. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7687224 ↗
• MalfunctionJul 3, 2018Device Displays Incorrect Message; Power Problem; Device Displays Incorrect Message; 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 7659987 ↗
• MalfunctionJun 19, 2018Failure to Analyze Signal; Failure to Analyze Signal

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WAS DISPLAYING THE 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 OBSERVED THAT THE DEVICE WOULD NO RECOGNIZE A SHOCKABLE RHYTHM. AS A RESULT, DEFIBRILLATION THERAPY WOULD NOT BE POSSIBLE, IF IT WAS NEEDED.

  Patient problems: No Patient Involvement

  MAUDE report 7613531 ↗
• MalfunctionMay 22, 2018Device Sensing Problem; Device Sensing Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE HAD A CHARGE-PAK AND SERVICE WRENCH PRESENT. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT. UPON EVALUATION OF THE CUSTOMER'S DEVICE, PHYSIO-CONTROL OBSERVED THAT THE DEVICE WOULD NOT CHARGE AND SHOCK A SHOCKABLE RHYTHM. AS A RESULT, DEFIBRILLATION WOULD NOT BE POSSIBLE IF IT WERE NECESSARY.

  Patient problems: No Patient Involvement

  MAUDE report 7535182 ↗
• MalfunctionApr 11, 2018Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE'S LID WOULD NOT CLOSE PROPERLY AND OPEN BY ITSELF. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT. UPON EVALUATION OF THE CUSTOMER'S DEVICE, PHYSIO-CONTROL OBSERVED THAT IT WOULD NOT POWER ON WHEN PROMPTED. AS A RESULT, DEFIBRILLATION WOULD NOT BE POSSIBLE IF IT WERE NECESSARY.

  Patient problems: No Patient Involvement

  MAUDE report 7423530 ↗
• MalfunctionApr 5, 2018Invalid Sensing; Device Sensing Problem; Invalid Sensing; Device Sensing Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE HAD A SERVICE WRENCH PRESENT ON THE READINESS DISPLAY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT. UPON EVALUATION OF THE CUSTOMER'S DEVICE, PHYSIO OBSERVED THAT NO MATTER WHAT ECG WAVEFORM WAS INPUT INTO IT, THE DEVICE WOULD ONLY READ THE WAVEFORM AS A FLAT LINE. AS A RESULT, THE DEVICE WOULD NOT BE ABLE TO DETECT A SHOCKABLE ECG WAVEFORM IN ORDER TO CHARGE AND SHOCK, IF IT WERE NECESSARY.

  Patient problems: No Patient Involvement

  MAUDE report 7400259 ↗
• MalfunctionMar 26, 2018No Audible Prompt/Feedback; No Audible Prompt/Feedback

  IT WAS REPORTED THAT THE CUSTOMER¿S DEVICE WOULD NOT PROVIDE ANY VOICE PROMPTS. WITHOUT VOICE PROMPTS, THE USER WOULD NOT ABLE TO USE THE DEVICE PROPERLY ON A PATIENT IF NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7372336 ↗