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

Model Number	1133943
Medical Device Problem Codes	Device Alarm System (1012); Crack (1135); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A simplygo mini device was returned to the manufacturer for inspection/evaluation.There is no allegation of patient harm.No clinical information or medical intervention was specified.During the evaluation, the manifold and compressor were replaced due to significant vibration and loud operating sound.The sieve canister was replaced due to the alarm indicating, "sieve canister needs to be checked." the power connector was replaced due to damage - no thermal damage or wires were exposed.After the comprehensive examination, the unit is operating correctly.

• Brand Name: SIMPLYGO MINI
• 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 15208 ; 4125423300
• MDR Report Key: 18568100
• Report Number: 2518422-2024-04039
• Device Sequence Number: 15238721
• Product Code: CAW
• UDI-Device Identifier: 00606959047440
• UDI-Public: 00606959047440
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

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: 1133943
• Device Catalogue Number: 1133943
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2023
• Initial Report FDA Received Date: 01/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2018
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown