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

Model Number 1025DS

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 regarding an oxygen concentrator by an external repair center, who stated that when they "began repair, the pc board started sparking when powered on." 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 found the main board to be defective due to a cold solder joint.The board was repaired and the unit is operating to specification.

• Brand Name: DEVIBISS
• 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 ; 99 seaview blvd.; ste 210; port washington, NY 11050 ; 5169984600
• MDR Report Key: 17894644
• MDR Text Key: 325250794
• Report Number: 2515872-2023-00083
• Device Sequence Number: 1
• Product Code: CAW
• UDI-Device Identifier: 00885304022466
• UDI-Public: 00885304022466
• 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: 10/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2023
• 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: 09/21/2023
• Date Manufacturer Received: 08/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2021
• 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