LIFEPAK® 12 defibrillator/monitor 99400 (REF 99400-000981)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00721902154553), received between Mar 20, 2019 and Aug 16, 2019 — classified as 3 malfunctions.

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

Recent adverse event reports

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

• MalfunctionAug 16, 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 AND THE DEVICE DID NOT DELIVER A SHOCK WHEN THEY ATTEMPTED TO SHOCK THE PATIENT. THEY WERE ABLE TO SWITCH TO A BACK UP DEVICE RIGHT AWAY AND USED THAT TO CONTINUE PATIENT CARE. THERE WERE NO REPORTS OF ANY ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE REPORTED ISSUE. THE CUSTOMER ADVISED PHYSIO-CONTROL THAT NO ADDITIONAL PATIENT INFORMATION IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8903867 ↗
• MalfunctionJul 18, 2019Failure to Power Up; Failure to Power Up

  IT WAS REPORTED TO PHYSIO-CONTROL THAT THE CUSTOMER'S DEVICE WOULD NOT POWER ON. 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 8803222 ↗
• MalfunctionMar 20, 2019Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THE APEX SHOCK BUTTON ON THEIR DEVICE'S HARD PADDLES ASSEMBLY DOES NOT RESPOND WHEN PRESSED. AS A RESULT, DEFIBRILLATION WITH THE HARD PADDLES WOULD NOT BE POSSIBLE IF IT WERE NECESSARY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8438610 ↗