LIFEPAK® 12 defibrillator/monitor 97400 (REF 97400-001371)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00883873950982), received between Aug 28, 2018 and Apr 8, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Failure to Power Up” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2024Failure to Power Up; Failure to Power Up

  A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NOT POWER ON. AS A RESULT, DEFIBRILLATION WOULD NOT BE AVAILABLE, IF NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19057627 ↗
• MalfunctionAug 15, 2019Unexpected Shutdown; Unexpected Shutdown

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE UNEXPECTEDLY LOST POWER TWICE DURING PATIENT CARE. 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 8896312 ↗
• MalfunctionJun 19, 2019Failure to Power Up; Failure to Power Up

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEY ATTEMPTED TO USE THIS DEVICE ON A PATIENT AND THE DEVICE WOULD NOT POWER ON. THE CUSTOMER SWITCHED TO A BACK UP DEVICE AFTER A 2 MINUTE DELAY. THERE WERE NO REPORTS OF ANY ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE REPORTED ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8712653 ↗
• MalfunctionNov 12, 2018Connection Problem; Connection Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT DURING AN EVENT, A SERVICE INDICATOR APPEARED. MEDICAL PERSONNEL WERE MONITORING A PATIENT AND THE UNIT CONTINUED TO OPERATE WITHOUT ANY DISCREPANCIES DURING THE EVENT. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE REPORTED ISSUE. UPON EVALUATION OF THE CUSTOMER'S DEVICE, PHYSIO-CONTROL OBSERVED THAT IT WOULD ONLY INTERMITTENTLY DETECT THAT A TEST PATIENT LOAD WAS CONNECTED VIA A THERAPY CABLE AND, AS A RESULT, DEFIBRILLATION WAS ONLY POSSIBLE INTERMITTENTLY. PHYSIO-CONTROL HAS ATTEMPTED TO CONTACT THE CUSTOMER IN ORDER TO OBTAIN ADDITIONAL DETAILS ABOUT THE PATIENT; HOWEVER, NO RESPONSE HAS BEEN RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8062442 ↗
• MalfunctionAug 28, 2018Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE DISPLAYED THE ¿SERVICE NEEDED¿ ACROSS THE DISPLAY DURING A PATIENT EVENT. THIS IS INDICATIVE OF A POTENTIAL DEVICE LOCK-UP. THE CUSTOMER ADVISED THAT DURING A TRANSPORT OF A PATIENT, AFTER HITTING A BUMP IN THE ROAD, THEIR DEVICE DISPLAY WENT BLANK AND THEN ¿SERVICE NEEDED¿ APPEARED ON THE SCREEN. WHEN THIS OCCURRED ALL LEDS BECAME ILLUMINATED AND REMAINED LIT. AFTER APPROXIMATELY 5 MINUTES THEY POWERED THE DEVICE OFF AND THEN BACK ON AGAIN, THEREAFTER NO FURTHER ISSUES WERE OBSERVED. THE CUSTOMER ADVISED THAT THERE WERE NO ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE REPORTED ISSUE. NO FURTHER DETAILS WERE PROVIDED. PHYSIO-CONTROL HAS MADE SEVERAL ATTEMPTS TO CONTACT THE CUSTOMER FOR FURTHER INFORMATION ON THE EVENT AND PATIENT, BUT HAS BEEN UNSUCCESSFUL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7824772 ↗