MAUDE Adverse Event Report: SUNSET OXYGEN SUPPLY TUBING

Model Number RES3050 AND RES3007

Device Problem Insufficient Information (3190)

Patient Problem Low Oxygen Saturation (2477)

Event Type  Injury  

Manufacturer Narrative

Maude adverse event report number mw5078464 alleges a consumer experienced a lower oxygen saturation when using sunset brand oxygen tubing and nasal cannula.The report also alleges the consumer experienced increased frequency of falls, dizziness, and elevated resting heart rate.The report alleges after using another brand of oxygen tubing, oxygen saturation increased when on the prescribed oxygen flow rate.A comparative analysis with other marketed oxygen tubing and an evaluation of current devices in stock will be performed.If the results of the evaluation demonstrate a malfunction, an additional narrative will be provided.

Event Description

Maude adverse event report number mw5078464.

• Brand Name: SUNSET OXYGEN SUPPLY TUBING
• Type of Device: OXYGEN SUPPLY TUBING
• Manufacturer Contact: nazree williams ; 180 n. michigan ave; suite 2000; chicago, IL 60601 ; 3125332457
• MDR Report Key: 8287170
• MDR Text Key: 134445301
• Report Number: 3006446479-2019-00004
• Device Sequence Number: 1
• Product Code: BYX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: RES3050 AND RES3007
• Device Catalogue Number: RES3050 AND RES3007
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/29/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1