MAUDE Adverse Event Report: DEVILBISS HEALTHCARE LLC DEVILBISS; NEBULIZER (DIRECT PATIENT INTERFACE)

Model Number 5650C

Device Problems Decrease in Pressure (1490); Smoking (1585)

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

Event Date 03/05/2024

Event Type  malfunction  

Event Description

Devilbiss healthcare was notified of an incident involving a nebulizer compressor by a service provider, who reported that the unit had low pressure during use, smelled burned and that treatment time took too long.When the end-user saw smoke emitting from the device, she stopped the device and completed her treatment with her back-up compressor.There was no report of patient harm or injury.Devilbiss is in the process of facilitating the return of the product for inspection and will update this report should any additional information become available.

• Brand Name: DEVILBISS
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): DEVILBISS HEALTHCARE LLC; 100 devilbiss drive; somerset PA 15501
• Manufacturer (Section G): DEVILBISS HEALTHCARE LLC; 100 devilbiss drive; somerset PA 15501
• Manufacturer Contact: jess bohrer ; 100 devilbiss drive; somerset, PA 15501
• MDR Report Key: 19016028
• MDR Text Key: 339106725
• Report Number: 2515872-2024-00018
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 00885304000884
• UDI-Public: 00885304000884
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K923888
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 5650C
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/05/2024
• Initial Date FDA Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1