MAUDE Adverse Event Report: SUNSET HEALTHCARE SOLUTIONS, INC. OXYGEN EXTENSION TUBING; CONNECTOR, AIRWAY (EXTENSION)

Device Problems Inaccurate Delivery (2339); Defective Device (2588)

Patient Problems Weakness (2145); Anxiety (2328); Low Oxygen Saturation (2477); Ambulation Difficulties (2544)

Event Date 11/01/2017

Event Type  Injury  

Event Description

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.

• Brand Name: OXYGEN EXTENSION TUBING
• Type of Device: CONNECTOR, AIRWAY (EXTENSION)
• Manufacturer (Section D): SUNSET HEALTHCARE SOLUTIONS, INC.
• MDR Report Key: 7609496
• MDR Text Key: 111453192
• Report Number: MW5077891
• Device Sequence Number: 1
• Product Code: BZA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 98 YR
• Patient Weight: 54