MAUDE Adverse Event Report: SALTER LABS OXYGEN TUBING

Model Number 2525-25

Device Problems Kinked (1339); Infusion or Flow Problem (2964)

Patient Problems Dyspnea (1816); Weakness (2145); Low Oxygen Saturation (2477); No Code Available (3191)

Event Type  Injury  

Event Description

I use two 10 liter (l) oxygen concentrators, with two short tubes hooked together with a "y" connector, which can supply up to 20l.Attached to the "y" connector i use two 25 oxygen tubes plus a 7 cannula, all hooked together with swivel connectors.This gives me a total of 57 + feet of tubing for use in the house.When i attach new tubing to the concentrators, the tubing will not lay flat on the floor, even after stretching.This becomes a trip hazard for both my (b)(6) wife and myself.After 2 or 3 days the tubing starts becoming tangled requiring me to disconnect it, straighten it out and reinstall it.Twice while it was tangled it became kinked, shutting off 8l of oxygen (tested later with a 0-15 liter meter).The second time this happened (on (b)(6)) i did not realize there was a problem until i became weak in the legs and short of breath.I checked the airflow at the cannula and there was none.I started following the tubing and finally found a kink close to the concentrators.By this time my oxygen saturation rate (spo2) had fallen into the low 70 percent range (checked with a digit spo2 meter).A few more minutes and i would have had to have help.This is an issue that has gone on for the last few years.When i was diagnosed with copd and went on oxygen, 11 years ago, the technician who installed the equipment at our home demonstrated how to stretch the tubing so it would lay flat and showed that it could not become kinked and stop the airflow.The tangling was not a problem as long as we used 25' lengths with swivel connectors.Today with the newer tubing, that is not working.

• Brand Name: OXYGEN TUBING
• Type of Device: OXYGEN TUBING
• Manufacturer (Section D): SALTER LABS
• MDR Report Key: 5946026
• MDR Text Key: 54659506
• Report Number: MW5064695
• Device Sequence Number: 1
• Product Code: BYX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 2525-25
• Device Catalogue Number: 2525-25
• Device Lot Number: (10)NOP101915
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 75 YR
• Patient Weight: 94