LIFEPAK® 15 monitor/defibrillator 99577 (REF 99577-001948)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00883873871782), received between Nov 28, 2018 and Oct 14, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Failure to Deliver Energy” (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

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 14, 2021Failure to Deliver Energy; Energy Output Problem; Failure to Deliver Energy; Energy Output Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WAS DELIVERING THE WRONG LEVEL OF DEFIBRILLATION ENERGY DURING TESTING. AS A RESULT, THE WRONG DEFIBRILLATION THERAPY MAY BE DELIVERED TO A PATIENT, IF NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT. UPON EVALUATION OF THE CUSTOMER'S DEVICE, PHYSIO-CONTROL OBSERVED EVENT CODES LOGGED IN THE DEVICE'S MEMORY. ONE EVENT CODE LOGGED IS INDICATIVE OF A FAILURE OF THE DEVICE TO DELIVER DEFIBRILLATION ENERGY. THE OTHER EVENT CODE IS INDICATIVE OF THE DEVICE DELIVERING A MONOPHASIC SHOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12632424 ↗
• MalfunctionAug 3, 2021Failure to Deliver Energy; Failure to Deliver Energy

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WOULD NOT DELIVER A SHOCK WHEN SHOCK BUTTON WAS PRESSED. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12272181 ↗
• MalfunctionJan 11, 2019Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEY WERE USING THIS DEVICE ON A PATIENT DURING A SYNCHRONIZED CARDIOVERSION PROCEDURE. WHEN THEY ATTEMPTED TO DELIVER A SHOCK TO THE PATIENT, THE DEVICE WOULD NOT DELIVER A SHOCK. THE CUSTOMER ALSO REPORTED THAT THE DEVICE LOGGED EVENT CODES IN ITS MEMORY THAT CAN BE INDICATIVE OF A FAILURE TO DELIVER DEFIBRILLATION ENERGY AND A DELIVERY OF A MONOPHASIC SHOCK. THERE WERE NO REPORTS OF ANY ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE REPORTED ISSUE. PHYSIO-CONTROL CONTACTED THE CUSTOMER TO REQUEST ADDITIONAL INFORMATION ON THE PATIENT. NO RESPONSE HAS BEEN RECEIVED FROM THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8242068 ↗
• MalfunctionNov 28, 2018Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEY WERE USING THIS DEVICE ON A PATIENT AND WHEN THEY ATTEMPTED TO SHOCK THE PATIENT, THE DEVICE DID NOT DELIVER A SHOCK. THE CUSTOMER REPORTED THAT THERE WERE NO ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE REPORTED ISSUE. NO ADDITIONAL INFORMATION ON THE PATIENT HAS BEEN PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8112945 ↗