MAUDE Adverse Event Report: RESPIRONICS, INC. EVERFLO OXYGEN CONCENTRATOR; GENERATOR, OXYGEN, PORTABLE

Model Number 1020001

Device Problems Electrical /Electronic Property Problem (1198); Mechanical Problem (1384); Material Integrity Problem (2978)

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

Event Date 06/14/2023

Event Type  malfunction  

Manufacturer Narrative

H3 other text: not returned to manufacturer.

Event Description

The device was returned to a third-party service center for service.There was no harm or injury reported.During the evaluation of the device at third-party service center these issues were observed: the capacitor burnt which caused front and rear cabinet damage; compressor wires were burned; intake filter was dirty; the connector tube was missing; beds high pressures; and leak tested.Post repair, red light alarming while running 95%-defective board.The device has not been returned to the manufacturer.At this time, the investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

The manufacture previously reported the device was returned to a third-party service center for service.There was no harm or injury reported.During the evaluation of the device at third-party service center these issues were observed: the capacitor burnt which caused front and rear cabinet damage; compressor wires were burned; intake filter was dirty; the connector tube was missing; beds high pressures; and leak tested.Post repair, red light alarming while running 95%-defective board.Correction has been made, initial reporter country united states, has been added.

• Brand Name: EVERFLO OXYGEN CONCENTRATOR
• Type of Device: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 17491895
• MDR Text Key: 321042629
• Report Number: 2518422-2023-19030
• Device Sequence Number: 1
• Product Code: CAW
• UDI-Device Identifier: 00606959022041
• UDI-Public: 00606959022041
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061261
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: 505
• Type of Report: Initial,Followup
• Report Date: 08/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 1020001
• Device Catalogue Number: 1020001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/16/2023
• Date Device Manufactured: 11/18/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1