MAUDE Adverse Event Report: UNKNOWN CPAP TUBING; TUBING, PRESSURE AND ACCESSORIES

Device Problems Collapse (1099); No Flow (2991)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/19/2019

Event Type  malfunction  

Event Description

Cpap hose that collapses when any bending is present.This is a new problem and it restricts the airway.I have woken to rapid breathing trying to catch my breath since the cpap was not flowing air.Have raised it with the provider and they sent another product that lasted 10 minutes until i turned.I have not suffered impact but others may suffer heart problems.I am unable to find older tubes that would not collapse.Online reviews are reporting this on all new hoses.I am cleaning and reusing my old hose.This should be investigated before someone dies.Bend the hose at the connection and see the thin plastic close up.

• Brand Name: CPAP TUBING
• Type of Device: TUBING, PRESSURE AND ACCESSORIES
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 8367248
• MDR Text Key: 137304109
• Report Number: MW5084343
• 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: 02/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 113