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

Model Number	1113602
Medical Device Problem Codes	Thermal Decomposition of Device (1071); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received a work order invoice for a simply go mini portable oxygen concentrator due to pca-technical fault and very low oxygen, the compressor had black residue in the tubing, the sieves were compacted, the air side was blackened and chirping, and the oxygen side was cracked.The faulty parts were replaced.There was no report of serious patient harm or injury.There was no report of medical intervention.At this time, no further investigation can be performed.If any additional information is received, a follow- up report will be filed.
Additional Manufacturer Narrative
The manufacturer previously received a work order invoice for a simplygo mini portable oxygen concentrator due to pca-technical fault and very low oxygen, the compressor had black residue in the tubing, the sieves were compacted, the air side was blackened and chirping, and the oxygen side was cracked.The faulty parts were replaced.There was no report of serious patient harm or injury.There was no report of medical intervention.After further review by the manufacturer, it was determined there was no evidence of a thermal event.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.Review of the risk file indicates the potential for a serious adverse event occurring as a result of the findings at service are unlikely.The complaint is considered not reportable.Mdr 2518422-2024-102126 was reported in error.The manufacturer has updated the device problem code in this report.

• Brand Name: SIMPLYGO MINI
• Common Device Name: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer Contact: melissa rosko ; 1001 murry ridge lane; murrysville, PA ; 7247330200
• MDR Report Key: 20461751
• Report Number: 2518422-2024-102126
• Device Sequence Number: 8811288
• Product Code: CAW
• UDI-Device Identifier: 00606959032408
• UDI-Public: (01)00606959032408
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K111885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• 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: Lay User/Patient
• Device Model Number: 1113602
• Device Catalogue Number: 1113602
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/16/2024
• Supplement Report FDA Received Date: 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/25/2018
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown