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

Model Number	1113605
Medical Device Problem Codes	Improper Flow or Infusion (2954); Noise, Audible (3273); Excessive Heating (4030)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 other text : device not returned to manufacturer.
Event or Problem Description
The manufacturer received information regarding a simplygo mini.The customer alleged the device runs irregularly, gets warm, and whistles.The device was returned to a third party service center.During visual inspection of the device, the device was found to have clogged sieves, and the air side, o2 side, and compressor were contaminated.The defective parts were replaced.The device was service, inspected, tested, and met acceptance criteria in accordance with all applicable customer requirements as defined in the contractual agreement with the third party service center.There was no allegation of serious or permanent harm or injury.No medical intervention was required for the patient.
Additional Manufacturer Narrative
The manufacturer previously reported information regarding a simplygo mini.The customer alleged the device runs irregularly, gets warm, and whistles.The device was returned to a third party service center.During visual inspection of the device, the device was found to have clogged sieves, and the air side, o2 side, and compressor were contaminated.The defective parts were replaced.The device was service, inspected, tested, and met acceptance criteria in accordance with all applicable customer requirements as defined in the contractual agreement with the third party service center.There was no allegation of serious or permanent harm or injury.No medical intervention was required for the patient.Update: after re-evaluation of the reported complaint/information, it has been determined that this complaint should have been deemed not reportable.Review of the risk file indicates the potential for a serious adverse event occurring as a result of this incident is unlikely.There was no patient harm or injury associated with this notification and no increased risk to the intended user.This device meets ul and iec requirements for flammability.Based on the information available, no mdr should have been filed.Section e: reporter country - updated from "australia" to "switzerland".

• Brand Name: SIMPLYGO MINI
• Common Device Name: PORTABLE 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: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 18370561
• Report Number: 2518422-2023-37041
• Device Sequence Number: 18094399
• Product Code: CAW
• UDI-Device Identifier: 00606959032439
• UDI-Public: 00606959032439
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K111885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup

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: Other
• Device Model Number: 1113605
• Device Catalogue Number: 1113605
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2023
• Supplement Date Received by Manufacturer: 12/09/2023
• Initial Report FDA Received Date: 12/21/2023
• Supplement Report FDA Received Date: 03/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/11/2021
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown