MAUDE Adverse Event Report: DEVILBISS HEALTHCARE LLC DRIVE; OXYGEN CONCENTRATOR

Model Number 525DS

Device Problem Sparking (2595)

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

Event Type  malfunction  

Event Description

Devilbiss healthcare was notified of a complaint involving an oxygen concentrator by a provider stating that "a spark came from underneath machine." there was no report or evidence of illness, injury or medical treatment associated with the complaint.The unit was returned to devilbiss for investigation and the root cause of the spark was the power cord being damaged at the strain relief, causing wires to be exposed.The power cord was replaced, and a full inspection was completed.The unit passed all manufacturing specifications and can now be used as intended.

• Brand Name: DRIVE
• Type of Device: OXYGEN CONCENTRATOR
• 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: jillian forster ; 100 devilbiss drive; somerset, PA 15501
• MDR Report Key: 17851963
• MDR Text Key: 324697311
• Report Number: 2515872-2023-00084
• Device Sequence Number: 1
• Product Code: CAW
• UDI-Device Identifier: 00885304000846
• UDI-Public: 00885304000846
• 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
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 10/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 525DS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2023
• Date Manufacturer Received: 01/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2019
• 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