LIFEPAK® 15 monitor/defibrillator 99577 (REF 99577-001243)Recalls & reported problems

Physio-Control, Inc. · 15AABAABABBBBAAAAAAAAAABLP15 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 00883873911761), received between Oct 3, 2018 and Mar 25, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Electrical /Electronic Property Problem1
Failure to Analyze Signal1
Key or Button Unresponsive/not Working1

Patient problems

No Clinical Signs, Symptoms or Conditions2
No Patient Involvement1

Recent adverse event reports

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

MalfunctionMar 25, 2025Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working
DURING ROUTINE PREVENTATIVE MAINTENANCE BY STRYKER, IT FOUND THAT THE CUSTOMER'S DEVICE'S KEYPAD WAS UNRESPONSIVE. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21689294 ↗
MalfunctionApr 5, 2022Failure to Analyze Signal; Failure to Analyze Signal
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE HAD LOGGED AN EVENT CODE IN THE MEMORY WHICH INDICATES THAT THE AED FUNCTION OF THE DEVICE MAY BE INOPERABLE. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO ANALYZE A PATIENT'S RHYTHM AND PROVIDE DEFIBRILLATION THERAPY WHILE IN AED MODE, IF NECESSARY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14015726 ↗
MalfunctionOct 3, 2018Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
THE CUSTOMER, A COMMERCIAL DISTRIBUTOR, CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE HAD LOGGED AN EVENT CODE IN ITS MEMORY CODE WHICH IS RELATED TO A POTENTIAL FAILURE OF THE DEVICE TO DELIVER DEFIBRILLATION ENERGY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Patient Involvement
MAUDE report 7930123 ↗

Device details

UDI-DI	`00883873911761`
Brand	LIFEPAK® 15 monitor/defibrillator
Model	99577
Catalog no.	99577-001243
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.

Other Automated external defibrillators (non-wearable) devices

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NA 861289
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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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