MAUDE Adverse Event Report: DEVILBISS HEALTHCARE LLC DEVILBISS; CONCENTRATOR

Model Number 1025DS

Device Problem Sparking (2595)

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

Event Type  malfunction  

Event Description

(b)(4) healthcare was notified by an authorized service center of a complaint involving an oxygen concentrator.The unit was sent to the service center for evaluation after the end user reported the unit line cord was "sparking." there was no report or evidence of illness, injury or medical treatment associated with the complaint.The service center returned the unit to (b)(4) for further investigation and root cause determination.Examination of the unit revealed evidence of physical damage, including broken screw bosses in the base and misalignment of the front cover.The line cord was damaged, as evidenced by abrasions and cuts at the point of the cord strain relief at the cabinet insert, which caused the internal wires of the cord to be visible.There was no evidence of electrical, thermal, or other damage to the inside of the unit.The line cord was replaced, and the unit operates to specification.

• Brand Name: DEVILBISS
• Type of Device: 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: roberto munoz ; 100 devilbiss drive; somerset, PA 15501
• MDR Report Key: 17321573
• MDR Text Key: 319232982
• Report Number: 2515872-2023-00058
• Device Sequence Number: 1
• Product Code: CAW
• UDI-Device Identifier: 00885304022466
• UDI-Public: 885304022466
• 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 Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 07/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1025DS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2021
• 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
• Patient Sex: Female