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

Model Number R1113608

Device Problems Thermal Decomposition of Device (1071); Contamination (1120); Crack (1135); No Display/Image (1183)

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

Event Date 06/21/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The manufacturer received information related to a simplygo mini oxygen concentrator.The device was evaluated by a third party service center.The service technician reports the pca board burnt, display not working, compressor defective, oxygen side and air side are contaminated, rear cover cracked, sieves clogged.

• 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: 18369230
• MDR Text Key: 331029823
• Report Number: 2518422-2023-36996
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 12/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: R1113608
• Device Catalogue Number: R1113608
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/21/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/11/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1