LIFEPAK® 15 monitor/defibrillator 99577 (REF 99577-000043)Recalls & reported problems
Physio-Control, Inc. · 15AABBABAABABAAAAAAAAAAALP15 MONITOR/DEFIB · Class 3
All models of LIFEPAK 15 monitor/defibrillator (93)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00883873988053), received between Jul 3, 2018 and Sep 6, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Inoperable” (1 report).
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
- Device Inoperable1
- Failure to Deliver Shock/Stimulation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 6, 2023Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation
THE CUSTOMER CONTACTED STRYKER TO REPORT A NON-CRITICAL ISSUE WITH THEIR DEVICE. UPON EVALUATION OF THE CUSTOMER¿S DEVICE, STRYKER OBSERVED THAT THE DEVICE DOES NOT PROVIDE DEFIBRILLATION ENERGY AS EXPECTED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17694783 ↗MalfunctionJul 3, 2018Device Inoperable; Device Inoperable
THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT INTERMITTENTLY THEIR DEVICE WOULD HAVE A BLANK DISPLAY AND THE SERVICE INDICATOR WOULD BE ILLUMINATED. IN THIS STATE DEFIBRILLATION THERAPY MAY NOT BE AVAILABLE TO A PATIENT IF NEEDED. THERE WAS NO PATIENT USE REPORTED FOR THIS EVENT. UPON EVALUATION OF THE CUSTOMER¿S DEVICE, PHYSIO-CONTROL OBSERVED THAT THE DEVICE WAS UNABLE TO COMPLETE A BOOT CYCLE AND HAD A BLANK DISPLAY.
Patient problems: No Patient Involvement
MAUDE report 7661152 ↗
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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