MAUDE Adverse Event Report: SALTER LABS OXYGEN SUPPLY TUBING; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Catalog Number	REF 2025G-25
Health Effect - Clinical Codes	Pain (1994); Peeling (1999); Skin Inflammation (2443)
Date of Event	02/08/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Had been suffering worsening sinus related issues.Seen n.P.On (b)(6) 2019 who ordered nasal swab for cerebral spinal fluid.On (b)(6) 2019, my bi-pap had increased to 2.5 per hour.My nose was red, peeling and painful.On (b)(6) 2018, i changed out all my oxygen, nebulizer , bi-pap equipment and filters.I rechecked the extension tubing on the oxygen concentration.The tubing was full of pin holes at the connection end on both sides for about 12 inches.I changed it and got more tubing from (b)(6), my dme company.My bi-pap settings improved to 0.6-1.0 and my sinus symptoms stopped.Today, my nose is starting to drip again.I am wheezing.My bi-pap settings are back up to 2.5, i checked the extension tubing on my oxygen concentration.I have the same situation.The tubing is full of pin holes at the connection ends for about 12 inches.I opened a new extension tubing to inspect it.The tubing itself has air bubbles visible in it , tiny ones.I believe that with use of the tubing and time that these air bubbles/weak seams are popping open creating pin holes in the extension tubing.I used two different types of tubing.One from salter labs ref 2025g-25.One from sunset res3015g.1 tube.Green.

• Brand Name: OXYGEN SUPPLY TUBING
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): SALTER LABS
• MDR Report Key: 8336387
• Report Number: MW5083975
• Device Sequence Number: 18883554
• Product Code: BZD
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 02/10/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: REF 2025G-25
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/12/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Weight: 59