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

Model Number 102000

Device Problem Leak/Splash (1354)

Patient Problem Low Oxygen Saturation (2477)

Event Date 01/07/2015

Event Type  Injury  

Event Description

The manufacturer received info alleging a patient's blood oxygen level was low while on an everflo oxygen concentrator.The patient was instructed by the durable medical equipment (dme) supplier to use their back up oxygen supply.There was no medical intervention required by the patient.

Manufacturer Narrative

The device was evaluated by a third party service center.The technician found the sieve canister to be leaking and the filters dirty.The sieve canister and filters were replaced to address the issue.

• Brand Name: EVERFLO OXYGEN CONCENTRATOR
• Type of Device: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): RESPIRONICS, INC.; kennesaw GA
• Manufacturer Contact: don mcandrews ; 1740 golden mile highway; monroeville, PA 15146 ; 7243873965
• MDR Report Key: 4501533
• MDR Text Key: 19765772
• Report Number: 1040777-2015-00004
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 102000
• Device Catalogue Number: 102000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2010
• 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): Required Intervention
• Patient Age: 86 YR