MAUDE Adverse Event Report: ROSCOE MEDICAL/COMPASS HEALTH BRANDS CPAP 6' TUBING; TUBING, PRESSURE AND ACCESSORIES

Model Number EASY-FLEX6

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dyspnea (1816); Chest Tightness/Pressure (2463)

Event Date 12/29/2018

Event Type  No Answer Provided  

Event Description

I used plastic tubing from a company roscoe for my cpap machine.The tubing attaches to the machine, which attaches to my mask and i breathe through it throughout the night.After breathing through the new roscoe tube, i awoke unable to breathe, sore throat, closed up throat, sinus distress, heavy chest.I changed back to my original tubing the next night and had no trouble, started to improve.Product description: connector on both ends.Dark gray.Retailer: (b)(6).Purchase date: (b)(6) 2018.Document number: (b)(4).

• Brand Name: CPAP 6' TUBING
• Type of Device: TUBING, PRESSURE AND ACCESSORIES
• Manufacturer (Section D): ROSCOE MEDICAL/COMPASS HEALTH BRANDS
• MDR Report Key: 8358820
• MDR Text Key: 137257533
• Report Number: MW5084159
• Device Sequence Number: 1
• Product Code: BYX
• 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: 02/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: EASY-FLEX6
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 66 YR