LIFEPAK® 15 monitor/defibrillator 99577 (REF 99577-001215)Recalls & reported problems

Physio-Control, Inc. · 15AABAABABBBBABAAAAAAAABLP15 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: 3
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00883873912812), received between Oct 14, 2019 and Feb 1, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Inappropriate/Inadequate Shock/Stimulation” (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

Inappropriate/Inadequate Shock/Stimulation2
Failure to Deliver Energy1

Patient problems

No Patient Involvement2
No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

MalfunctionFeb 1, 2022Failure to Deliver Energy; Failure to Deliver Energy
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 WAS UNABLE TO DELIVER DEFIBRILLATION ENERGY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13409772 ↗
MalfunctionApr 28, 2020Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation
THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE IS DELIVERING ABNORMAL ENERGY. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER APPROPRIATE DEFIBRILLATION THERAPY IF NEEDED. THERE WAS NO PATIENT USE REPORTED WITH THE EVENT.
Patient problems: No Patient Involvement
MAUDE report 10007546 ↗
MalfunctionOct 14, 2019Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation
THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE FAILED THE USER TEST. UPON EVALUATION OF THE CUSTOMER'S DEVICE, PHYSIO OBSERVED THAT THE DEVICE WAS DELIVERING A MONOPHASIC ENERGY OUTPUT INSTEAD OF A BIPHASIC OUTPUT AND DISPLAYED AN ABNORMAL ENERGY DELIVERY MESSAGE. AS A RESULT, THE INCORRECT DEFIBRILLATION THERAPY MAY BE DELIVERED. THERE WAS NO PATIENT USE ASSOCIATED WITH THIS EVENT.
Patient problems: No Patient Involvement
MAUDE report 9189178 ↗

Device details

UDI-DI	`00883873912812`
Brand	LIFEPAK® 15 monitor/defibrillator
Model	99577
Catalog no.	99577-001215
Company	Physio-Control, Inc.
Product code	MKJ · Automated external defibrillators (non-wearable)
Class	Class 3
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	MR Unsafe
Status	In Commercial Distribution
Record updated	Mar 29, 2018

Device type (GMDN): Physiologic-monitoring defibrillation system

An assembly of electrically-powered devices designed to defibrillate the heart that incorporates additional therapeutic and/or monitoring features intended to resuscitate and/or monitor a cardiac patient. It typically includes devices that enable manual and/or automated external defibrillation (a defibrillator) and one or more of the following: electrocardiogram (ECG) monitoring (electrocardiograph), noninvasive cardiac pacing (temporary pacemaker), cardioversion (CV), pulse oximetry (oximeter), invasive and/or noninvasive blood pressure monitoring, and end-tidal carbon dioxide (EtCO2) monitoring (i.e., a CO2 monitor). It may have data recording/printing capabilities.

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All Automated external defibrillators (non-wearable) devices →

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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