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

Model Number	1113601
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer became aware of an allegation of a simply go mini stating that the device is getting a tech fault alarm.The device was returned to a third- party service center for evaluation.During the evaluation of the device, the device they found out that the pca of the burned battery.In addition, failures in battery pca burned, rp-simply go mini-compressor contaminated, r-air side manifold assembly, sgm contaminated, rp-simply go mini rear enclosure damage, simply go mini front cover damage.Rp-sgm warning label intlrist.Error codes are found in the device.The compressor, battery pca, sieve bed canister are going to be replaced.The device was routed to scrap.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.

• Brand Name: SIMPLYGO MINI
• Common Device Name: PORTRABLE OXYGEN CONCENTRATOR
• Manufacturer (Section D): RESPIRONICS, INC.; 6501 living place; pittsburgh PA 15208
• Manufacturer (Section G): RESPIRONICS, INC.; 6501 living place; pittsburgh PA 15208
• Manufacturer Contact: melissa rosko ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 21124281
• Report Number: 2518422-2025-001744
• Device Sequence Number: 8733079
• Product Code: CAW
• UDI-Device Identifier: 00606959032392
• UDI-Public: (01)00606959032392
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/10/2025

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: 1113601
• Device Catalogue Number: 1113601
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2024
• Initial Report FDA Received Date: 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/11/2023
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown