LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors 99507 (REF 99507-000112)Recalls & reported problems
Physio-Control, Inc. · CONFIG LP20E CMM,ENG · Class 3
All models of LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors (23)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00883873853962), received between Jan 1, 2021 and Jan 1, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Power Problem” (1 report).
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
Device problems
- Power Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 1, 2021Power Problem; Power 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 BY STRYKER, IT WAS NOTED THAT THE DEVICE WAS NOT POWERING ON WITH EITHER AC OR DC POWER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11103555 ↗
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, ClassifiedLIFEPAK 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-2497-2025 · Jul 22, 2025 · Open, ClassifiedLIFEPAK 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-2498-2025 · Jul 22, 2025 · Open, ClassifiedLIFEPAK 1000 Part / Catalog Numbers / UDI-DI code: 320371500023 / 99425-000025 / 885074698953 320371500229 / 99425-000025 / 885074698953 331706400001 / 99425-000025 / 885074698953
- Z-1232-2025 · Feb 3, 2025 · Open, ClassifiedLIFEPAK 20e REF 99507-000001 The AED mode is to be used only on patients in cardiopulmonary arrest.
- Z-1184-2025 · Jan 21, 2025 · Open, ClassifiedLIFEPAK 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, ClassifiedLIFEPAK 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, ClassifiedAC Power Adapter for use with the LIFEPAK 15 Monitor/Defibrillator, REF: 11140-000098
- Z-0300-2024 · Sep 29, 2023 · Open, ClassifiedLIFEPAK 15, REF: 99577-001373, Part Number V15-7-000002
- Z-0298-2024 · Sep 29, 2023 · Open, ClassifiedLIFEPAK 15, REF: 99577-000061, Part Number V15-2-000067
- Z-0297-2024 · Sep 29, 2023 · Open, ClassifiedLIFEPAK 15, REF: 99577-000055, Part Number V15-2-000061
- Z-0302-2024 · Sep 29, 2023 · Open, ClassifiedLIFEPAK 15, REF: 99577-001956, Part Number V15-7-000021
- Z-0305-2024 · Sep 29, 2023 · Open, ClassifiedLIFEPAK 15, REF: 99577-001960, Part Number: V15-7-000026
- Z-0304-2024 · Sep 29, 2023 · Open, ClassifiedLIFEPAK 15, REF: 99577-001958, Part Number: V15-7-000023
- Z-0296-2024 · Sep 29, 2023 · Open, ClassifiedLIFEPAK 15, REF: 99577-000046, Part Number V15-2-000051
- Z-0301-2024 · Sep 29, 2023 · Open, ClassifiedLIFEPAK 15, REF: 99577-001955, Part Number V15-5-000584 and V15-7-000020
…and 2 more.
Other Automated external defibrillators (non-wearable) devices
- NA 861290Philips Medical Systems Hsg · Automated External Defibrillators (Non-Wearable)12 deaths5,167 reports
- NA 861288Philips Medical Systems Hsg · Automated External Defibrillators (Non-Wearable)21 deaths5,015 reports
- NA 861289Philips Medical Systems Hsg · Automated External Defibrillators (Non-Wearable)7 deaths3,385 reports
- R SERIES 30001005201310012Zoll Medical Corporation · Automated external defibrillators (non-wearable)10 deaths1,720 reports
- PHILIPS HeartStart FRxPhilips Electronics North America Corporation · Automated external defibrillators (non-wearable)26 deaths1,586 reports
- LIFEPAK CR2 99512Physio-Control, Inc. · Automated external defibrillators (non-wearable)8 deaths1,502 reports
- Lifeline Configuration DDU-100ADefibtech, L.L.C. · Automated External Defibrillators (Non-Wearable)1 death1,285 reports
- PHILIPS HeartStart FR3Philips Electronics North America Corporation · Automated External Defibrillators (Non-Wearable)10 deaths1,188 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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