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

Model Number 1113600

Device Problem Failure to Power Up (1476)

Patient Problems Respiratory Failure (2484); Insufficient Information (4580)

Event Date 03/15/2023

Event Type  Death  

Manufacturer Narrative

H3 other text: device not yet returned to manufacturer.

Event Description

A consumer reported the portable oxygen concentrator was no longer functioning after 6 weeks of use.At the time of the initial report, the patient had gone without use of the device for two days due to the device not functioning.A manager at the store where the device was purchased alleges the device was defective and the manager would not exchange the device.During an attempt to obtain additional information regarding this complaint, and an attempt to retrieve the device, an adult child of the patient reported the patient passed away two months ago.There was no medical intervention specified.The device will not be returned for evaluation.The user manual states the device is not intended for life support.Where the prescribing health care professional has determined that an interruption in the supply of oxygen, for any reason, may have serious consequences to the user, an alternate source of oxygen should be available for immediate use.The user manual also states the philips respironics simplygo mini portable oxygen concentrator is for prescription use by patients requiring high concentrations of oxygen on a supplemental basis.

Manufacturer Narrative

The manufacturer previously reported that an portable oxygen concentrator was no longer functioning after 6 weeks of use.At the time of the initial report, the patient had gone without use of the device for two days due to the device not functioning.A manager at the store where the device was purchased alleges the device was defective and the manager would not exchange the device.During an attempt to obtain additional information regarding this complaint, and an attempt to retrieve the device, an adult child of the patient reported the patient passed away two months ago.There was no medical intervention specified.The device will not be returned for evaluation.The user manual states the device is not intended for life support.Where the prescribing health care professional has determined that an interruption in the supply of oxygen, for any reason, may have serious consequences to the user, an alternate source of oxygen should be available for immediate use.The user manual also states the philips respironics simplygo mini portable oxygen concentrator is for prescription use by patients requiring high concentrations of oxygen on a supplemental basis.Additional information was received by the patient's daughter stating that the patient's death was due to respiratory failure.

• Brand Name: SIMPLYGO MINI DEVICE
• Type of Device: PORTABLE OXYGEN CONCENTRATOR
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 17586519
• MDR Text Key: 321564935
• Report Number: 2518422-2023-20287
• Device Sequence Number: 1
• Product Code: CAW
• UDI-Device Identifier: 00606959032385
• UDI-Public: 00606959032385
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1113600
• Device Catalogue Number: 1113600
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/24/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death