MAUDE Adverse Event Report: DEVILBISS HEALTHCARE LLC DEVILBISS; NEBULIZER

Model Number 6910D-DR

Device Problem Fire (1245)

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

Event Date 08/25/2021

Event Type  malfunction  

Event Description

Devilbiss healthcare is the manufacturer of the device which is a nebulizer.We are awaiting return of the device for evaluation.A follow-up report will be submitted when additional data is available.We are filing this report in an over abundance of caution.The device was acquired one year ago.The user never noticed it overheating or a burning smell before.However, within the last week he noticed the noise level of the device increased.The device started smoking and caught on fire during the user's regular morning treatment.He changed the filters and updated the hoses as necessary.No injuries occurred nor did any property damage.

• Brand Name: DEVILBISS
• Type of Device: NEBULIZER
• Manufacturer (Section D): DEVILBISS HEALTHCARE LLC; 100 devilbiss drive; somerset PA 11501
• Manufacturer (Section G): DEVILBISS HEALTHCARE; 100 devilbiss drive; somerset PA 11501
• Manufacturer Contact: patricia beja ; 100 devilbiss drive; somerset, PA 11501 ; 5169984600
• MDR Report Key: 12543633
• MDR Text Key: 273680007
• Report Number: 2515872-2021-00009
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 00885304002529
• UDI-Public: 885304002529
• Combination Product (y/n): N
• PMA/PMN Number: K031413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 09/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 6910D-DR
• Date Manufacturer Received: 08/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1