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

Model Number 900-000-02

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem Respiratory Distress (2045)

Event Date 10/22/2014

Event Type  Injury  

Event Description

The mfr received info alleging an everflo oxygen concentrator had low oxygen output.The pt was admitted to the hosp, but has since been released.The reporting facility stated the pt has other health issues that may have contributed to the pt being hospitalized.

Manufacturer Narrative

The device was returned to the mfr for eval.The mfr confirmed the customer's complaint of the device having low oxygen output.The device was found to have a leaking compressor.The sieve and compressor were replaced to address the issue.

• Brand Name: EVERGO OXYGEN CONCENTRATOR
• Type of Device: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): RESPIRONICS, INC.; kennesaw GA
• Manufacturer Contact: don mcandrews ; 1740 golden mile hwy; monroeville, PA 15146 ; 7243873965
• MDR Report Key: 4256117
• MDR Text Key: 5046440
• Report Number: 1040777-2014-00029
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043615
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 900-000-02
• Device Catalogue Number: 900-000-02
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/03/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/22/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2010
• 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): Hospitalization