MAUDE Adverse Event Report: DEVILBISS HEALTHCARE LLC DEVILBISS; NEBULIZER

Model Number 3655LT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 02/26/2021

Event Type  Death  

Event Description

Devilbiss healthcare became aware of the incident from a communication by the service provider.The patient's girlfriends notified the service provider's billing department of patient's death.Service provider's staff visited the residence and found home damaged by fire.Patient's girlfriend stated that his death was unrelated to the fire.We have received the fire report noting suspected arson.There were multiple fires in the dwelling fueled by stacked furnishings.We have not received the device for evaluation.Since it was lost in the fire.

• Brand Name: DEVILBISS
• Type of Device: NEBULIZER
• 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: patricia beja ; 100 devilbiss drive; somerset, PA 15501 ; 5169984600
• MDR Report Key: 12394330
• MDR Text Key: 269033935
• Report Number: 2515872-2021-00013
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 00885304001782
• UDI-Public: 885304001782
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020932
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 3655LT
• Date Manufacturer Received: 03/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death