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

Model Number IT1113605

Device Problem Failure to Power Up (1476)

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

Event Date 07/21/2023

Event Type  malfunction  

Event Description

The manufacturer received information regarding a simply go mini device.The device was returned to a third-party service center.During visual inspection of the device, the pca was found to be burnt.This report is being submitted for the burnt pca found during service.There was no allegation of serious or permanent harm or injury.No medical intervention was required for the patient.

Manufacturer Narrative

H3 other text : sent to a third-party service center.

• 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: 18278989
• MDR Text Key: 329900721
• Report Number: 2518422-2023-33998
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K111885
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• 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: 12/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: IT1113605
• Device Catalogue Number: IT1113605
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/21/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/06/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1