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

Model Number 1113605

Device Problems Crack (1135); Insufficient Flow or Under Infusion (2182); Battery Problem (2885)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/09/2023

Event Type  malfunction  

Manufacturer Narrative

H3 other text: device evaluated by third party service center.

Event Description

The manufacturer received information in relation to a simplygo mini oxygen concentrator.The device was returned to a third party service center.A service technician evaluated the device.The service technician reports low oxygen, sieves need replaced, air side and oxygen side defective, cracked at screw place, warning label needs replaced, battery needs to be replaced due to not charging.The device was serviced and all issues were corrected.

• Brand Name: SIMPLYGO MINI
• Type of Device: 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: 18211566
• MDR Text Key: 329037970
• Report Number: 2518422-2023-31775
• Device Sequence Number: 1
• Product Code: CAW
• UDI-Device Identifier: 00606959032439
• UDI-Public: 00606959032439
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K111885
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 1113605
• Device Catalogue Number: 1113605
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/09/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/11/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1