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

Model Number 525DS

Device Problem No Audible Alarm (1019)

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

Event Date 11/22/2021

Event Type  malfunction  

Event Description

During a retrospective complaint review, (b)(6) identified an oxygen concentrator with complaint of "unit alarms not functional." there was no report or evidence of illness, injury or medical treatment associated with the complaint.(b)(6) evaluated the unit and determined that the root cause of the condition was a defective pc board.The board was serviced and the device now meets manufacturer specifications.

• Brand Name: DEVILBISS
• Type of Device: GENERATOR, OXYGEN, PORTABLE
• 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 ; 99 seaview blvd; suite 210; port washington, NY 11050 ; 5169984600
• MDR Report Key: 17405524
• MDR Text Key: 320144324
• Report Number: 2515872-2023-01039
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 525DS
• Device Catalogue Number: 525DS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2021
• Date Manufacturer Received: 11/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1