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

Model Number 1113604

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/14/2023

Event Type  malfunction  

Event Description

The manufacturer was contacted in reference to a portable oxygen concentrator by a patient who alleges that no oxygen was coming through when breathing.The patient reported there was a "no breath" sign displayed on the device.There is no allegation of serious or permanent harm or injury.The device was returned to the manufacturer.During evaluation of the device, the unit was run and the fault was confirmed.Inspection was performed and there were no problems found with any of the piping.The touch screen was faulty and only worked intermittently.The unit was also in need of a new front housing, sieves, and inlet filters.The device was serviced and parts were changed, and the unit was run again.The faults were resolved and the unit was delivering oxygen as expected.The keypad and display were working as expected as well.

Manufacturer Narrative

Evaluation results code grid - amended from "software problem identified" to "interoperability problem identified - incompatible/component accessory".Conclusion code grid - amended from "cause traced to software coding" to "cause traced to maintenance".

• Brand Name: SIMPLYGO MINI
• 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: 18026418
• MDR Text Key: 326817318
• Report Number: 2518422-2023-28045
• Device Sequence Number: 1
• Product Code: CAW
• UDI-Device Identifier: 00606959032422
• UDI-Public: 00606959032422
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 10/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1113604
• Device Catalogue Number: 1113604
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2023
• Date Manufacturer Received: 06/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1