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

Model Number 900-020-02

Device Problems Loose or Intermittent Connection (1371); Failure to Deliver (2338)

Patient Problem No Information (3190)

Event Date 06/02/2015

Event Type  Injury  

Event Description

The manufacturer received information alleging an evergo oxygen concentrator was not delivering oxygen.The patient was taken to the hospital.It is unknown what medical treatment was provided to the patient.The device was returned and evaluated by the manufacturer's service center.The manufacturer found the wiring harness to the pca to be loose causing the device to not produce oxygen.The wiring harness was replaced to address the issue.

• Brand Name: EVERGO 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; 175 chastain meadows court; kennesaw GA 30144
• Manufacturer Contact: wilfredo alvarez ; 1740 golden mile highway; monroeville 15146 ; 7243875658
• MDR Report Key: 4868603
• MDR Text Key: 15235802
• Report Number: 1040777-2015-00027
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K043615
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 900-020-02
• Device Catalogue Number: 900-020-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/22/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization