LIFEPAK® 15 monitor/defibrillator 99577 (REF 99577-001947)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00883873871799), received between Oct 18, 2018 and Dec 22, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Sensing 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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 22, 2023Failure to Deliver Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation; Failure to Deliver Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  THE CUSTOMER CONTACTED STRYKER TO REPORT THAT AFTER A SHOCK THEIR DEVICE SHOWED "ABNORMAL SHOCK DETECTED" MESSAGE. THE CUSTOMER ALSO REPORTED THAT TWO EVENT CODES WERE LOGGED IN THE MEMORY OF THEIR DEVICE. THE FIRST EVENT CODE LOGGED IN ITS MEMORY INDICATES A DEVICE FAILURE THAT COULD RESULT IN A PARTIAL LOSS OF DEFIBRILLATOR OUTPUT ENERGY DUE TO A LOSS OF THE NEGATIVE PORTION OF THE BIPHASIC OUTPUT WAVEFORM, RESULTING IN A MONOPHASIC SHOCK. THE SECOND EVEN CODE LOGGED IN ITS MEMORY IS RELATED TO A POTENTIAL FAILURE OF THE DEVICE TO DELIVER DEFIBRILLATION ENERGY. IN THIS STATE THE DEVICE WOULD BE INOPERABLE AND DEFIBRILLATION THERAPY WOULD NOT BE AVAILABLE, IF NEEDED. THERE WERE NO REPORTS OF ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18382479 ↗
• MalfunctionOct 18, 2018Device Sensing Problem; Device Sensing Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT A NON-CRITICAL ISSUE WITH THEIR DEVICE. UPON EVALUATION OF THE CUSTOMER¿S DEVICE, PHYSIO-CONTROL OBSERVED THAT THE DEVICE WAS UNABLE TO DETECT THE CONNECTION OF THE DEFIBRILLATION THERAPY CABLE ASSEMBLY. IN THIS STATE, THE DEVICE WOULD BE INOPERABLE AND DEFIBRILLATION THERAPY WOULD NOT BE AVAILABLE IF NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7981400 ↗