LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors 99402 (REF 99402-000065)Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00883873813812), received between Apr 18, 2019 and Aug 9, 2021 — classified as 1 injury, 18 malfunctions.

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

17 other recalls cover devices cleared under the same FDA submission (P160026); 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 9, 2021Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE IS DELIVERING DEFIBRILLATION OUT OF TOLERANCE. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER APPROPRIATE DEFIBRILLATION THERAPY IF NEEDED. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12297498 ↗
• MalfunctionFeb 23, 2021Connection Problem; Connection Problem; Device Sensing Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE FAILED TO DETECT ATTACHMENT TO THE PATIENT. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11363768 ↗
• MalfunctionOct 16, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  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'S DISPLAY WAS WHITE. A WHITE DISPLAY CAN BE INDICATIVE OF A DEVICE LOCK UP CONDITION. AS A RESULT, DEFIBRILLATION THERAPY MAY BE UNAVAILABLE, IF NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10693734 ↗
• MalfunctionSep 28, 2020Electrical /Electronic Property Problem; Unexpected Shutdown; Electrical /Electronic Property Problem; Unexpected Shutdown

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT DURING TESTING THEIR DEVICE'S DISPLAY WENT COMPLETELY GRAY AND THEN UNEXPECTEDLY POWERED OFF. A BLANK DISPLAY CAN BE INDICATIVE OF A DEVICE LOCK UP CONDITION. AS A RESULT, DEFIBRILLATION THERAPY MAY BE UNAVAILABLE, IF NEEDED. THERE WAS NO REPORTED OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10597917 ↗
• MalfunctionSep 4, 2020Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WAS CHARGED TO 200J DURING A CODE WHEN IT TWICE POWERED DOWN BEFORE IT WAS ABLE TO DELIVER A SHOCK. THE CLINICIANS WERE THEN ABLE TO USE ANOTHER DEVICE AND DELIVER THERAPY SUCCESSFULLY. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THERE WAS NO REPORT OF ANY ADVERSE EFFECT TO THE PATIENT AS A RESULT OF THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10497471 ↗
• MalfunctionMay 4, 2020Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WILL NOT POWER ON CORRECTLY, AND THAT THEY MUST REPEATEDLY PUSH THE ON BUTTON. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 10020131 ↗
• InjuryMar 30, 2020Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT WHEN APPLYING THERAPY SHOCK TO THE PATIENT THEIR DEVICE SCREEN WENT GREEN AND WAS NOT ABLE TO PROVIDE THERAPY SHOCK. THE CUSTOMER REPORTED ADVERSE CONSEQUENCES REQUIRING THEM TO GATHER ANOTHER MONITOR TO PERFORM THERAPY MEASURES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9898069 ↗
• MalfunctionMar 25, 2020Display or Visual Feedback Problem; Defibrillation/Stimulation Problem; Display or Visual Feedback Problem; Defibrillation/Stimulation Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE DISPLAYED A SOLID GREEN SCREEN AND WAS "NOT ABLE TO PROVIDE THERAPY SHOCK". THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE PATIENT OUTCOME REPORTED. A SECOND DEVICE WAS USED AND THE PATIENT SURVIVED THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9881315 ↗
• MalfunctionFeb 28, 2020Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WOULD NOT POWER ON. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 9770629 ↗
• MalfunctionFeb 26, 2020Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WOULD NOT POWER ON WITH EITHER AC OR DC POWER. THERE WAS NO PATIENT USE REPORTED WITH THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9760217 ↗
• MalfunctionJan 17, 2020Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE INTERMITTENTLY DISPLAYED A BLANK SCREEN. IN THIS STATE THE DEVICE WOULD NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THERE WAS NO PATIENT USE REPORTED WITH THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9604357 ↗
• MalfunctionDec 12, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WAS BOOTING UP WITH A WHITE DISPLAY. A WHITE DISPLAY CAN BE INDICATIVE OF A DEVICE LOCK UP CONDITION. AS A RESULT, DEFIBRILLATION THERAPY MAY BE UNAVAILABLE, IF IT IS NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9457480 ↗
• MalfunctionOct 11, 2019Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE UNEXPECTEDLY POWERED OFF WHILE THEY WERE USING IT ON A PATIENT. THERE WERE NO REPORTS OF ANY ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE REPORTED ISSUE. THE CUSTOMER ADVISED PHYSIO-CONTROL THAT NO ADDITIONAL PATIENT INFORMATION IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9180205 ↗
• MalfunctionAug 30, 2019Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE IS NOT POWERING ON. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8952548 ↗
• MalfunctionAug 16, 2019Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEY WERE USING THIS DEVICE ON A PATIENT IN VENTRICULAR TACHYCARDIA. WHEN THEY ATTEMPTED TO DELIVER A SHOCK TO THE PATIENT, THE DEVICE WOULD NOT DELIVER A SHOCK. THERE WERE NO REPORTS OF ANY ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE REPORTED ISSUE. THE CUSTOMER ADVISED PHYSIO-CONTROL THAT NO ADDITIONAL PATIENT INFORMATION IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8903771 ↗
• MalfunctionJun 24, 2019Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT WHILE PERFORMING ANNUAL PREVENTATIVE MAINTENANCE ON THEIR DEVICE, THE SERVICE INDICATOR ILLUMINATED AND THE DEVICE LOGGED MULTIPLE EVENT CODES IN THE DEVICE'S MEMORY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED ISSUE. UPON EVALUATION OF THE CUSTOMER'S DEVICE, PHYSIO-CONTROL OBSERVED THAT THE DEVICE DELIVERED "ABNORMAL ENERGY" WHEN ATTEMPTING TO DELIVER 15 JOULES AND GREATER. AS A RESULT, THE WRONG DEFIBRILLATION THERAPY WOULD BE DELIVERED, IF IT WERE NECESSARY.

  Patient problems: No Patient Involvement

  MAUDE report 8729060 ↗
• MalfunctionMay 31, 2019Defective Component; Connection Problem; Defective Component; Connection Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WILL NOT ALLOW A THERAPY CABLE TO BE CONNECTED TO IT. THERE SEEMS TO BE A BROKEN PIN INSIDE THE THERAPY CONNECTOR. AS A RESULT, DEFIBRILLATION THERAPY MAY BE UNAVAILABLE, IF IT WAS NEEDED.

  Patient problems: No Patient Involvement

  MAUDE report 8659756 ↗
• MalfunctionMay 23, 2019Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE LOGGED A CRITICAL EVENT CODE WHILE PERFORMING PREVENTATIVE MAINTENANCE. THE EVENT CODE IS INDICATIVE OF A DEVICE ISSUE THAT COULD RESULT IN A PARTIAL LOSS OF DEFIBRILLATOR OUTPUT ENERGY DUE TO A LOSS OF THE NEGATIVE OR POSITIVE PORTION OF THE BIPHASIC OUTPUT WAVEFORM. THE DEFIBRILLATOR OUTPUT ENERGY COULD BE REDUCED BY UP TO APPROXIMATELY 20% FROM THE SELECTED ENERGY LEVEL. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8638499 ↗
• MalfunctionApr 18, 2019Energy Output Problem; Energy Output Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE FAILED THE USER TEST AND HAS AN EVENT CODE LOGGED IN ITS MEMORY. THE EVENT CODE LOGGED IN THE DEVICE'S MEMORY IS INDICATIVE OF A DEVICE FAILURE THAT COULD RESULT IN A PARTIAL LOSS OF DEFIBRILLATOR OUTPUT ENERGY DUE TO A LOSS OF THE NEGATIVE PORTION OF THE BIPHASIC OUTPUT WAVEFORM, RESULTING IN A MONOPHASIC SHOCK. ADDITIONALLY, THE DEFIBRILLATOR OUTPUT ENERGY MAY BE REDUCED BY UP TO APPROXIMATELY 20% FROM THE SELECTED ENERGY LEVEL. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 8529607 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P160026. One submission often covers many models, so check the product and lot details in each record.

• Z-2065-2026 · Apr 13, 2026 · Open, Classified
  LIFEPAK 15, REF: 99577-000025, 99577-000047, 99577-001256, 99577-001217, 99577-001241, 99577-001255, 99577-001219, 99577-001957, 99577-001935, 99577-001964, 99577-001955, 99577-001
• Z-2498-2025 · Jul 22, 2025 · Open, Classified
  LIFEPAK 1000 Part / Catalog Numbers / UDI-DI code: 320371500023 / 99425-000025 / 885074698953 320371500229 / 99425-000025 / 885074698953 331706400001 / 99425-000025 / 885074698953
• Z-2497-2025 · Jul 22, 2025 · Open, Classified
  LIFEPAK 15 Part / Catalog Numbers / UDI-DI code: V15-7-000022 / 99577-001957 / 883873871690 V15-2-000051 / 99577-000046 / 883873988022 V15-2-000099 / 99577-000093 / 883873979020 V
• Z-1232-2025 · Feb 3, 2025 · Open, Classified
  LIFEPAK 20e REF 99507-000001 The AED mode is to be used only on patients in cardiopulmonary arrest.
• Z-1184-2025 · Jan 21, 2025 · Open, Classified
  LIFEPAK 15 V4/Masimo Rainbow Sensors: Masimo RD rainbow Adt 8 SpCO, SpO2, and SpMet, Adult Adhesive Sensors REF 11996-000515 Masimo LNCS-II rainbow DCI 8 SpCO, Adult Reusable Sen
• Z-0230-2025 · Aug 30, 2024 · Open, Classified
  LIFEPAK 15 (LP15) Model/Catalog Numbers: o 97577-000101 o 99577-000046 o 99577-000055 o 99577-000061 o 99577-000076 o 99577-001250 o 99577-001255 o 99577-001256 o 99577-001368 o 99
• Z-0567-2024 · Nov 6, 2023 · Open, Classified
  AC Power Adapter for use with the LIFEPAK 15 Monitor/Defibrillator, REF: 11140-000098
• Z-0298-2024 · Sep 29, 2023 · Open, Classified
  LIFEPAK 15, REF: 99577-000061, Part Number V15-2-000067
• Z-0296-2024 · Sep 29, 2023 · Open, Classified
  LIFEPAK 15, REF: 99577-000046, Part Number V15-2-000051
• Z-0304-2024 · Sep 29, 2023 · Open, Classified
  LIFEPAK 15, REF: 99577-001958, Part Number: V15-7-000023
• Z-0302-2024 · Sep 29, 2023 · Open, Classified
  LIFEPAK 15, REF: 99577-001956, Part Number V15-7-000021
• Z-0305-2024 · Sep 29, 2023 · Open, Classified
  LIFEPAK 15, REF: 99577-001960, Part Number: V15-7-000026
• Z-0303-2024 · Sep 29, 2023 · Open, Classified
  LIFEPAK 15, REF: 99577-001957, Part Number V15-5-000586 and V15-7-000022
• Z-0300-2024 · Sep 29, 2023 · Open, Classified
  LIFEPAK 15, REF: 99577-001373, Part Number V15-7-000002
• Z-0301-2024 · Sep 29, 2023 · Open, Classified
  LIFEPAK 15, REF: 99577-001955, Part Number V15-5-000584 and V15-7-000020

…and 2 more.