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

Model Number 1113605

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 05/10/2023

Event Type  malfunction  

Manufacturer Narrative

H3 other text : device not returned to manfacturer.

Event Description

The manufacturer received information regarding a simplygo mini.The device was returned to a third party service center.During visual inspection of the device, the device was found to have a contaminated compressor.The air sieve was contaminated, the o2 side screw thread was damaged, and the sieve was clogged.The front cover was damaged.Also, the alarm sensor had damaged wire.There was no allegation of serious or permanent harm or injury.No medical intervention was required for the patient.

• 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: 18323724
• MDR Text Key: 330428547
• Report Number: 2518422-2023-35368
• 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,Foreign,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: 12/13/2023
• 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: 05/10/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/23/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1