MAUDE Adverse Event Report: SUNSET HEALTHCARE SOLUTIONS, INC OXYGEN SUPPLY TUBING; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number RES3015G

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

Patient Problems Pain (1994); Peeling (1999); Skin Inflammation (2443)

Event Date 02/08/2019

Event Type  Injury  

Event 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
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): SUNSET HEALTHCARE SOLUTIONS, INC
• MDR Report Key: 8336387
• MDR Text Key: 136718163
• Report Number: MW5083975
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00848530061067
• UDI-Public: (01)00848530061067(11)180928(10)
• 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
• Type of Report: Initial
• Report Date: 02/10/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/28/2018
• Device Model Number: RES3015G
• Device Catalogue Number: RES3015G
• Device Lot Number: 18009314
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Weight: 59