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

Model Number 1020015

Device Problems Failure to Power Up (1476); Device Inoperable (1663)

Patient Problems Fall (1848); Patient Problem/Medical Problem (2688)

Event Date 09/16/2015

Event Type  Injury  

Event Description

The manufacturer received information alleging an everflo oxygen concentrator overheated and shut off during the night while in patient use.The patient awakened in the morning and fell, breaking two toes.The patient alleges memory loss has occurred because of lack of oxygen.The patient was admitted to the hospital.A back up supply of oxygen was provided to the patient but was not reportedly used at the time of the event.The device has yet to be returned to the manufacturer for evaluation.A follow up report will be submitted when the manufacturer has completed the investigation.

Manufacturer Narrative

The manufacturer received additional information from a third party service center regarding an everflo oxygen concentrator that overheated and shut off during the night while in patient use.During the evaluation of the device at a third party service center, the customer's complaint was confirmed.The compressor, sieve and valve were replaced to address the issue.Evaluation conclusion: the third party service center replaced the sieve canister.

• Brand Name: EVERFLO Q 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 ; 312 alvin drive; new kensington, PA 15068 ; 7243349303
• MDR Report Key: 5169443
• MDR Text Key: 29002882
• Report Number: 1040777-2015-00035
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• PMA/PMN Number: K061261
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1020015
• Device Catalogue Number: 1020015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/11/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/29/2012
• 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: 80 YR