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

Model Number 1069058

Device Problem Failure to Power Up (1476)

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

Event Date 06/29/2023

Event Type  malfunction  

Event Description

The manufacturer became aware of an allegation that a simplygo device had a failure description of a triangle with arch to the right.There was no report of patient harm or injury.During the evaluation of the device at a third-party service center was observed low o2, sieve needs to be replaced, muffler kit, both pressure valve and tubing are contaminated with black dust, inlet filter needs to be changed due to preventive maintenance, compressor does not start.The manufacturer is submitting a final report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.

• Brand Name: SIMPLYGO,INTERNATIONAL
• 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: 18010380
• MDR Text Key: 326561607
• Report Number: 2518422-2023-27548
• Device Sequence Number: 1
• Product Code: CAW
• UDI-Device Identifier: 00606959020801
• UDI-Public: 00606959020801
• 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
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 1069058
• Device Catalogue Number: 1069058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2023
• Date Manufacturer Received: 06/29/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/25/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1