Natus 515-015300Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00382830037433), received between Apr 10, 2019 and Oct 9, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Smoking” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionOct 9, 2024Fire; Smoking; Fire; Smoking

  PART 515-015300 EDX BASE UNIT - THE CUSTOMER REPORTED THAT THE BASE UNIT IS NOT WORKING. A CAPACITOR BLEW ON ONE OF THE BOARDS AND IT CAUGHT FIRE. NO INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20410696 ↗
• MalfunctionFeb 21, 2024Sparking; Sparking

  PART 515-015300 EDX BASE UNIT - POWER ON SYSTEM AND UNIT SPARKED. THE EQUIPMENT STARTED PULSING WHILE UNATTENDED. THE STAFF HEARD IT AND UNPLUGGED THE SYSTEM BECAUSE IT WAS SMOKING. THERE WAS ALSO A BURNT PLASTIC LIKE SMELL. THE CUSTOMER THEN RE-PLUGGED THE MACHINE, IT STARTED PULSING AND SMOKING AGAIN. NO INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18746352 ↗
• MalfunctionApr 10, 2019Smoking; Smoking

  EDX BASE STARTED TO SMOKE HEAVILY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8499958 ↗