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

Model Number R1098833

Device Problems Insufficient Flow or Under Infusion (2182); Material Deformation (2976); Noise, Audible (3273)

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

Event Date 01/03/2024

Event Type  malfunction  

Event Description

The manufacturer was contacted in reference to a simplygo device.The device was returned to the manufacturer and was visually inspected and evaluated and the following issues were found: degradation of the sieve canister, deformation of the inlet filter and tube, noise coming from the compressor, and the power connector installed in the housing was wobbly.The manufacturer replaced the inlet filter kit, tubing, enclosure kit, and the compressor; because the flow volume was less than the prescribed value when the sleep mode was set to 2.0, the main board was replaced.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
• 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: 18543013
• MDR Text Key: 333240575
• Report Number: 2518422-2024-03442
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 01/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: R1098833
• Device Catalogue Number: R1098833
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1