MAUDE Adverse Event Report: VYAIRE MEDICAL CPAP DRUCKSCHLAUCH AS PRO; PRESSURE MONITORING TUBING

Catalog Number 706422

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

Patient Problem Skin Irritation (2076)

Event Date 02/08/2019

Event Type  Injury  

Manufacturer Narrative

Other - a photo evaluation and interview was conducted by a vyaire medical representative.Upon further investigation, no product problem could be determined.The most likely cause of the irritation was due to the cleaning solution utilized by the user-facility for the tubing.

Event Description

Initial information reported that a patient had come into the practice with "burn injuries" on the neck.He brought the t3 with which a cpap check was carried out.The pressure measuring tube ran along the patient's neck, because the connection of the mask was located on top of the head.She was informed that the device was not heated, so it could not get hot.They assume it is an allergic reaction.Further investigation revealed the tubing had rubbed the patient throughout the night, and the practice determined it was an irritation, no allergic reaction.A liquid disinfectant, instruextra (1% concentration), is used between each use.Medical intervention of ointment to the affect area was provided.A few days later, the reported was reported to be fine.

Manufacturer Narrative

Additional information: the customer provided the additional information, confirming the silicone tube had been in contact with the patient's skin overnight, which resulted in an irritation and redness of the skin.It was also confirmed that there was no burn or heat.

• Brand Name: CPAP DRUCKSCHLAUCH AS PRO
• Type of Device: PRESSURE MONITORING TUBING
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• MDR Report Key: 8405030
• MDR Text Key: 138276819
• Report Number: 9615102-2019-00102
• Device Sequence Number: 1
• Product Code: MNR
• Combination Product (y/n): N
• PMA/PMN Number: K000396
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 706422
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/12/2019
• Initial Date FDA Received: 03/08/2019
• Supplement Dates Manufacturer Received: 02/12/2019
• Supplement Dates FDA Received: 11/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention