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

Model Number	1113600
Medical Device Problem Codes	Low Readings (2460); Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a simplygo mini oxygen concentrator have evidence of thermal damage to the enclosure.There was no report of patient harm or injury.The device has yet to be returned for evaluation.A follow up report will be submitted when the manufacturer has completed the investigation.
Additional Manufacturer Narrative
The manufacturer previously reported a simplygo mini oxygen concentrator alleging evidence of thermal damage to the enclosure.There was no report of patient harm or injury.The device was evaluated by a third party service center.The tecnician found the device to have low oxygen purity.The sieve cannister kit , sieve side assembly were replaced to address the issue.The technician found the inlet filter to be dirty.The inlet filter was replaced to address the issue.The technician found no evidence of thermal damage to the device.
Additional Manufacturer Narrative
In section d4 unique identifier (udi) number and in section g4 premarket identification number has been corrected in this report.

• Brand Name: SIMPLYGO MINI OXYGEN CONCENTRATOR
• Common Device Name: GENERATOR, OXYGEN, PORTABLE
• 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 15206 ; 2673970028
• MDR Report Key: 12970926
• Report Number: 2518422-2021-06898
• Device Sequence Number: 17179693
• Product Code: CAW
• UDI-Device Identifier: 00606959032385
• UDI-Public: 00606959032385
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K111885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 1113600
• Device Catalogue Number: 1113600
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2021
• Supplement Date Received by Manufacturer: 10/05/2022; 07/26/2023
• Initial Report FDA Received Date: 12/09/2021
• Supplement Report FDA Received Date: 02/23/2023; 07/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/06/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown