MAUDE Adverse Event Report: TRUDELL MEDICAL INTERNATIONAL AEROECLIPSE II BREATH ACTUATED NEBULIZER WITH UNIVERSAL TUBING; NEBULIZER (DIRECT PATIENT INTERFACE)

Model Number 64594050

Device Problem Melted (1385)

Patient Problem Insufficient Information (4580)

Event Date 07/26/2021

Event Type  malfunction  

Event Description

Patient completed nebulizer.Rn went to detach the tubing from the bottom of the nebulizer to allow the parts to air dry.Rn was unable to detach tubing from nebulizer, it appears it was, melted on.Piece was previously able to be removed prior to nebulizer treatment.

• Brand Name: AEROECLIPSE II BREATH ACTUATED NEBULIZER WITH UNIVERSAL TUBING
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): TRUDELL MEDICAL INTERNATIONAL; 5 latour ave.; suite 1600; plattsburgh NY 12901
• MDR Report Key: 12312337
• MDR Text Key: 266239181
• Report Number: 12312337
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 64594050
• Device Catalogue Number: 64594050
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/04/2021
• Event Location: Hospital
• Date Report to Manufacturer: 08/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other