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

Model Number 1069058

Device Problems Device Emits Odor (1425); Overheating of Device (1437); Device Contamination with Chemical or Other Material (2944); Noise, Audible (3273); Excessive Heating (4030)

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

Event Date 06/29/2023

Event Type  malfunction  

Manufacturer Narrative

H3 other text : device not returned to manufacturer.

Event Description

The manufacturer became aware of an allegation that a simplygo device was contaminated, low oxygen purity, noisy, thermally stressed and component found burnt.Replaced filter (s)/filter cap, sieve bed, compressor and main pca.There was no report of patient harm or injury.There was no report of medical intervention.There was no report of flames, smoking, melting or warping.

Manufacturer Narrative

The manufacturer previously reported an allegation that a simplygo device was contaminated, low oxygen purity, noisy, thermally stressed and component found burnt.Replaced filter (s)/filter cap, sieve bed, compressor and main pca.There was no report of patient harm or injury.There was no report of medical intervention.There was no report of flames, smoking, melting or warping.Update: due date and become aware date updated.Section a: patient identifier updated.Age added.Gender added.Event date added.Section h: (device) problem code grid updated.Evaluation method code grid updated.Evaluation results code grid updated.Related/duplicate ra (b)(4).

• 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: 18655516
• MDR Text Key: 334730322
• Report Number: 2518422-2023-25807
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K111885
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1069058
• Device Catalogue Number: 1069058
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/18/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/24/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1