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

Model Number 1068987

Device Problems Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Patient Problem/Medical Problem (2688); No Known Impact Or Consequence To Patient (2692)

Event Date 10/28/2015

Event Type  Injury  

Event Description

The manufacturer received information alleging a simply go oxygen concentrator was not working properly.The patient was admitted to the hospital and placed on a ventilator.The device has yet to be returned to the manufacturer for evaluation.A follow up report will be filed when the manufacturer has completed the investigation.

Manufacturer Narrative

The manufacturer previously reported a simplygo oxygen concentrator was allegedly not working properly.Repeated attempts to have the device returned for evaluation and investigation were unsuccessful.The manufacturer believes they will be unable to gather additional information.The manufacturer is submitting a final report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.

• Brand Name: SIMPLYGO 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: 5250475
• MDR Text Key: 32137919
• Report Number: 1040777-2015-00042
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111885
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 1068987
• Device Catalogue Number: 1068987
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/20/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/10/2015
• 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
• Patient Age: 51 YR