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

Model Number 1020001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Respiratory Tract Infection (2420)

Event Date 06/08/2016

Event Type  Injury  

Event Description

The manufacturer received information alleging the patient had a lung infection while using an everflo oxygen concentrator.The patient stated the durable medical equipment (dme) supplier, (b)(4), did not instruct the patient to change the nasal cannula and humidifier and has been using the same equipment for 3 years.The nasal canula was not manufactured or placed into distribution by respironics and the manufacturer of the cannula is unknown to the manufacturer.The patient reported to the manufacturer of the concentrator that he has been to the emergency room and has been kept overnight for observation several times because of the lung infection.He was prescribed antibiotics and steroids to treat the infection.The dme has been made aware of the complaint, so they may notify the cannula manufacturer of this event.The manufacturer concludes that the alleged event is caused by user error.There was no allegation of device malfunction.

• Brand Name: EVERFLO OXYGEN CONCENTRATOR
• Type of Device: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): RESPIRONICS INC; 175 chastain meadows court; kennesaw GA 30144
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: wilfredo alvarez ; 312 alvin drive; new kensington, PA 15068 ; 7243349303
• MDR Report Key: 5778215
• MDR Text Key: 49032795
• Report Number: 1040777-2016-00019
• Device Sequence Number: 1
• Product Code: CAW
• 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: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 1020001
• Device Catalogue Number: 1020001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/08/2016
• Initial Date FDA Received: 07/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2012
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR