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

Model Number 1068987

Device Problem Unexpected Shutdown (4019)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 12/11/2018

Event Type  malfunction  

Event Description

The manufacturer received information alleging a simplygo oxygen concentrator shut down while in patient use.The patient fainted and was taken to the hospital and placed on life support.The patient was in the hospital for 6 days.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 allegedly shut down while in patient use.The patient fainted and was taken to the hospital and placed on life support.The patient was in the hospital for 6 days.The device was returned to the manufacturer for evaluation.The customer's complaint was confirmed.The device shut down due to increased pressure within the sieve canisters.The sieve was replaced to address the issue.

• Brand Name: SIMPLYGO OXYGEN CONCENTRATOR
• Type of Device: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): RESPIRONICS, INC.; 175 chastian meadows court; kennesaw GA 30144 3724
• MDR Report Key: 8282209
• MDR Text Key: 134239975
• Report Number: 1040777-2019-00006
• Device Sequence Number: 1
• Product Code: CAW
• UDI-Device Identifier: 00606959005723
• UDI-Public: 00606959005723
• Combination Product (y/n): N
• PMA/PMN Number: K111885
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 01/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1068987
• Device Catalogue Number: 1068987
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2019
• Date Manufacturer Received: 02/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 48 YR