MAUDE Adverse Event Report: DEVILBISS HEALTHCARE, LLC DEVILBISS; PORTABLE OXYGEN GENERATOR

Model Number 525DS

Device Problem Use of Device Problem (1670)

Patient Problem Burn(s) (1757)

Event Date 09/25/2020

Event Type  Injury  

Event Description

Drive devilbiss healthcare is the distributor of the device which is a portable oxygen generator.Devilbiss healthcare, llc , a subsidiary of drive devilbiss, is the device manufacturer.Devilbiss has retrieved the device for evaluation.We will file a follow-up report when the evaluation is completed.The unit was in use.The end-user dropped a cigarette on the unit.There was a reaction to the cigarette.The end-user was taken to the hospital.Diagnosis and treatment unknown at this time.The manual and warning labels on the device indicate "no smoking allowed.".

• Brand Name: DEVILBISS
• Type of Device: PORTABLE OXYGEN GENERATOR
• Manufacturer (Section D): DEVILBISS HEALTHCARE, LLC; 100 devilbiss drivesomerset; somerset PA 15501
• Manufacturer (Section G): DEVILBIIS HEALTHCARE, LLC; devilbiss healthcare, llc; 100 devilbiss drive; somerset PA 15501
• Manufacturer Contact: patricia beja ; 100 devilbiss drive; somerset, PA 15501 ; 5169984600
• MDR Report Key: 10750105
• MDR Text Key: 216681903
• Report Number: 2515872-2020-00001
• Device Sequence Number: 1
• Product Code: CAW
• UDI-Device Identifier: 00885304016991
• UDI-Public: 885304016991
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071397
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 525DS
• Date Manufacturer Received: 09/25/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2020
• 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): Hospitalization