OXYGEN EXTENSION TUBING

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-15 for OXYGEN EXTENSION TUBING manufactured by Sunset Healthcare Solutions, Inc..

Event Text Entries

[111453192] Reporter alleges her mother suffered adverse effects during the use of oxygen extension tubing. Reporter advised she is the caregiver for her mother and noticed that her mother's oxygen saturation decreased significantly with readings below 90 percent accompanied by decreased appetite, ambulation difficulties, anxiety and general weakness. The extension tubing pops off from the concentrator and this deprives her mother from getting the required oxygen needed. Reporter alleges this brand has a wider diameter lumen when compared with a different tubing. Also, reporter alleges the material is stiff and rigid. She believes this defect affects the amount of oxygen delivered through the tubing. Reporter advised that on (b)(6) 2018 her mother was taken to the care center due to uncontrolled dyspnea episodes. During the visits the health professionals switched out the tubing and allegedly the oxygen saturation increased to 90 percent. Reporter believes the low oxygen reading was due to the extension tubing not delivering adequate oxygen.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5077891
• MDR Report Key: 7609496
• Date Received: 2018-06-15
• Date of Report: 2018-06-15
• Date of Event: 2017-11-01
• Date Added to Maude: 2018-06-18
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT FAMILY MEMBER OR FRIEND
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: OXYGEN EXTENSION TUBING
• Generic Name: CONNECTOR, AIRWAY (EXTENSION)
• Product Code: BZA
• Date Received: 2018-06-15
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: SUNSET HEALTHCARE SOLUTIONS, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2018-06-15