MAUDE Adverse Event Report: RESPIRONICS, INC.; NEBULIZER

Model Number 999998

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/17/2023

Event Type  malfunction  

Manufacturer Narrative

H3 other text : device not returned to the manufacturer.

Event Description

The manufacturer received information alleging a nebulizer is currently working but the back of the device is broke, and wires are exposed.There was no harm or injury reported.Several attempts were made to gather additional information in regard to the patient and device but were unsuccessful.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

Previously reported: the manufacturer received information alleging a nebulizer is currently working but the back of the device is broke, and wires are exposed.There was no harm or injury reported.Several attempts were made to gather additional information in regard to the patient and device but were unsuccessful.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.Correction to section e: initial reporter country was originally reported as canada.This event occurred in california, usa.

• Type of Device: NEBULIZER
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 18864293
• MDR Text Key: 337195721
• Report Number: 2518422-2024-12741
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 999998
• Device Catalogue Number: 999998
• Date Manufacturer Received: 10/17/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1