inforMED
MalfunctionCAF

18081

Received Nov 1, 2024

Report 3003188183-2024-90005 · MDR key 20585205

Device

Generic name

Nebulizer

Model number

18081

Product problems

  • Temperature Problem
  • Temperature Problem

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

VEGA FOUND THE MDR REPORT ON THE FDA WEBSITE AS ATTACHMENT 1 MDR NO. (B)(4). MDR REPORT CONTENTS. IMMEDIATELY PULLED THE POWER CORD AND THREW THE NEBULIZER OUT THE DOOR." THERE WAS NO REPORT OR EVIDENCE OF ILLNESS, INJURY OR MEDICAL TREATMENT ASSOCIATED WITH THE COMPLAINT. DRIVE IS CURRENTLY INVESTIGATING THE INCIDENT, INCLUDING ATTEMPTING TO RETRIEVE THE PRODUCT AND INSPECT IT, AND WILL FILE AN UPDATE IF ADDITIONAL INFORMATION BECOMES AVAILABLE. NG QTY: (B)(4) PCS.

Description of Event or Problem

VEGA FOUND THE MDR REPORT ON THE FDA WEBSITE AS ATTACHMENT 1 MDR NO. 2438477-2022-00069 MDR REPORT CONTENTS[?]IMMEDIATELY PULLED THE POWER CORD AND THREW THE NEBULIZER OUT THE DOOR." THERE WAS NO REPORT OR EVIDENCE OF ILLNESS, INJURY OR MEDICAL TREATMENTASSOCIATED WITH THE COMPLAINT. DRIVE IS CURRENTLY INVESTIGATING THE INCIDENT, INCLUDING ATTEMPTING TO RETRIEVE THE PRODUCT AND INSPECT IT, AND WILL FILEAN UPDATE IF ADDITIONAL INFORMATION BECOMES AVAILABLE. NG Q'TY:1PCS