LIFEPAK® 15 monitor/defibrillator 99577 (REF 99577-001938)Recalls & reported problems
Physio-Control, Inc. · 15AACBABBABBABAAAAAAAAAFLP15 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 00883873872017), received between May 10, 2018 and May 10, 2018 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Failure To Run On AC/DC” (2 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
Device problems
- Failure To Run On AC/DC2
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 10, 2018Failure To Run On AC/DC; Failure To Run On AC/DC
THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THE ON BUTTON ON THEIR DEVICE WOULD ONLY RESPOND INTERMITTENTLY WHEN PRESSED. THE CUSTOMER FURTHER ADVISED THEIR DEVICE POWERED OFF BY ITSELF DURING AN EVENT. THERE WERE NO REPORTS OF ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE REPORTED ISSUE. PHYSIO-CONTROL HAS ATTEMPTED TO CONTACT THE CUSTOMER IN ORDER TO OBTAIN ADDITIONAL INFORMATION ABOUT THE PATIENT AND THE EVENT; HOWEVER, NO RESPONSE HAS BEEN RECEIVED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7503396 ↗MalfunctionMay 10, 2018Failure To Run On AC/DC; Failure To Run On AC/DC
THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THE ON BUTTON ON THEIR DEVICE WOULD ONLY RESPOND INTERMITTENTLY WHEN PRESSED. THE CUSTOMER FURTHER ADVISED THEIR DEVICE POWERED OFF BY ITSELF DURING AN EVENT. THERE WERE NO REPORTS OF ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE REPORTED ISSUE. PHYSIO-CONTROL HAS ATTEMPTED TO CONTACT THE CUSTOMER IN ORDER TO OBTAIN ADDITIONAL INFORMATION ABOUT THE PATIENT AND THE EVENT; HOWEVER, NO RESPONSE HAS BEEN RECEIVED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7503394 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page