Kendall 31319281 (UDI 20884527008428)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20884527008428), received between Aug 3, 2020 and Jul 19, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Failure to Deliver Shock/Stimulation” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionJul 19, 2021Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  THE CUSTOMER REPORTED THAT DURING DEFIBRILLATION OF A PATIENT, THE DEFIB ELECTRODE DID NOT WORK. THE MACHINE DID NOT DETECT THE PADS SO IT COULD NOT CHARGE TO DEFIBRILLATE THEREFORE AN INTERNAL DEFIBRILLATOR WAS NEEDED DURING THE EMERGENCY. THE CUSTOMER FURTHER STATED THAT THE USER TEST HAD BEEN COMPLETED IN THE MORNING, THE DEVICE WAS FUNCTIONAL. THE INTEGRITY OF THE WIRES AND THE LOCATION OF THE PADS WERE COMPLIANT. THE CUSTOMER STATED THIS INCIDENT RESULTED IN A DELAY IN DEFIBRILLATION AND ALSO CAUSED STRESS FOR THE STAFF ALREADY IN EMERGENCY SITUATIONS. ADDITIONAL INFORMATION PROVIDED ON (B)(6) 2021 STATED THAT THE EXTERNAL PADS WERE PUT IN PLACE BEFORE THE SURGERY AND DURING THE PROCEDURE, THE INTERNAL PADDLES WERE USED. THE DELAY WAS 5 MINUTES. NO OTHER TREATMENT OR INTERVENTION WAS REQUIRED. NO INJURIES REPORTED. THE PATIENT'S STATUS IS NORMAL. ADDITIONAL INFORMATION PROVIDED ON JULY 29, 2021 STATED THAT THE DEFIBRILLATOR MODEL USED WAS A LIFEPAK 15 FROM STRYKER. ADDITIONAL INFORMATION PROVIDED ON AUGUST 19, 2021 STATED THAT THE FACILITY HAS DONE TESTS ON THE LIFEPAK15 GBM 2007776 DEFIBRILLATOR ACCORDING TO THE PERFORMANCE INSPECTION PROCEDURES OF THE TECHNICAL MANUAL. THEY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12189683 ↗
• MalfunctionAug 3, 2020Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED THAT THE METAL WAS SEPARATE OF THE GEL PAD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10359741 ↗