LIFEPAK® 12 defibrillator/monitor 97400 (REF 97400-001373)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00883873950968), received between Oct 30, 2018 and Mar 26, 2019 — 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.

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.

• MalfunctionMar 26, 2019Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE DID NOT SWITCH TO THE SECOND BATTERY WHEN THE FIRST BATTERY WAS DEPLETED AND UNEXPECTEDLY POWERED OFF. THE CUSTOMER ADVISED PHYSIO-CONTROL THAT THERE WERE NO ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE REPORTED ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8454305 ↗
• MalfunctionNov 8, 2018Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  THE CUSTOMER, A BIOMEDICAL ENGINEER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WOULD NOT DISPLAY THE JOULE ENERGY LEVEL DURING A PATIENT EVENT. THE CUSTOMER ADVISED THAT THE ENERGY LEVEL WAS NOT DISPLAYED ON THEIR DEVICE AND THEY WERE UNABLE TO CHANGE THE ENERGY (IT IS UNKNOWN IF THEY WERE UNABLE TO CHANGE THE ENERGY LEVEL DUE TO A CONTROL ISSUE OR BECAUSE THEY WERE UNABLE TO SEE THE ENERGY LEVEL BEING SELECTED). THEY WERE ABLE TO CHARGE THE DEVICE FOR DEFIBRILLATION AND SUCCESSFULLY SHOCK THE PATIENT, HOWEVER THEY DID NOT KNOW WHAT ENERGY LEVEL WAS DELIVERED. IN ADDITION, THE CUSTOMER ADVISED THAT THEIR DEVICE SERVICE INDICATOR HAD ILLUMINATED WHEN THE DEFIBRILLATION ELECTRODES WERE CONNECTED TO THE PATIENT. IN THIS STATE, WRONG DEFIBRILLATION THERAPY WOULD BE DELIVERED TO THE PATIENT. THIS ISSUE IS PATIENT RELATED; HOWEVER THE CUSTOMER ADVISED THAT THERE WAS NO ADVERSE PATIENT OUTCOME. PHYSIO-CONTROL CONTACTED THE CUSTOMER IN ORDER TO OBTAIN ADDITIONAL INFORMATION ABOUT BOTH THE PATIENT AND THE EVENT, HOWEVER, THE CUSTOMER WAS UNABLE PROVIDE FURTHER INFORMATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8053229 ↗
• MalfunctionOct 30, 2018Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER, A BIOMEDICAL ENGINEER, CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE DISPLAYED A SERVICE INDICATOR AND AN ORANGE COLORED BLANK SCREEN. BASED ON THE INFORMATION REPORTED, PHYSIO WAS UNABLE TO CONCLUDE IF THE ISSUE WAS RELATED TO THE DISPLAY ONLY (AND THE DEVICE¿S SOFTWARE WAS FUNCTIONAL) , OR IF THERE WAS A POWER RELATED DISCREPANCY. AS A RESULT, DEFIBRILLATION MAY BE DELAYED, OR PREVENT, IF IT WERE NECESSARY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8020396 ↗