MAUDE Adverse Event Report: SUNSET HEALTHCARE SOLUTIONS SUNSET; OXYGEN SUPPLY TUBING

Device Problem Insufficient Information (3190)

Patient Problems Low Oxygen Saturation (2477); Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

Maude adverse event report number mw5077891 alleges a consumer experienced decreased oxygen saturation readings below 90 percent, decreased appetite, ambulation difficulties, anxiety and general weakness when using sunset oxygen tubing.The report alleges the consumer was seen at a care center for dyspnea.The report also alleges the tubing disconnects from the oxygen concentrator.Due to limited information provided and the physical sample not being available, investigation into the sample is not possible.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 mw5077891.

• Brand Name: SUNSET
• Type of Device: OXYGEN SUPPLY TUBING
• Manufacturer (Section D): SUNSET HEALTHCARE SOLUTIONS; 180 n. michigan ave; suite 2000; chicago IL 60601
• Manufacturer (Section G): SUNSET HEALTHCARE SOLUTIONS; 180 n. michigan ave; suite 2000; chicago IL 60601
• Manufacturer Contact: nazree williams ; 180 n. michigan ave; suite 2000; chicago, IL 60601 ; 3125332457
• MDR Report Key: 8287127
• MDR Text Key: 134574199
• Report Number: 3006446479-2019-00003
• 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

• Date FDA Received: 01/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• 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