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

Model Number 1068987

Device Problems Failure to Deliver (2338); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 12/24/2019

Event Type  Injury  

Event Description

The manufacturer received information alleging a oxygen concentrator was not working during a flight.The battery allegedly was depleted prior to the flight.The patient was admitted to the hospital.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 previously reported an oxygen concentrator that alleged was not working during a flight.The battery allegedly was depleted prior to the flight.The patient was admitted to the hospital.The device was returned to the manufacturer's investigation laboratory for further evaluation.The device's downloaded event log was reviewed by the manufacturer.The event log confirmed the device was in use without having the batteries charged.The device visually and audibly alarmed and shut off.The device was tested and was found to operate and alarm to design specifications.Product labeling states,"make sure the battery is properly inserted and sufficiently charged.(the battery should be fully charged the first time you use it.).The device is not a life support device.

• Brand Name: SIMPLYGO OXYGEN CONCENTRATOR
• Type of Device: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): PHILIPS RESPIRONICS INC.; 312 alvin drive; new kensington PA 15068 3724
• MDR Report Key: 9532198
• MDR Text Key: 174512624
• Report Number: 1040777-2019-00051
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• PMA/PMN Number: K111885
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• 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: 12/31/2019
• Date Manufacturer Received: 01/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 43 YR