MAUDE Adverse Event Report: VYAIRE MEDICAL, INC CONNECTOR U/ADAPIT STR 22MM ID X 22MM OD; CONNECTOR, AIRWAY (EXTENSION)

Catalog Number 004081-A

Device Problem Melted (1385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/21/2017

Event Type  Injury  

Manufacturer Narrative

Initial emdr submission: sample is available, (b)(6) shipping labels provided to customer to have the sample returned.Currently awaiting for the sample.Once the investigation is complete a follow up submission will be filed.

Event Description

We have begun to investigate all our patients with this adapter and o2 with sleep equipment to visually inspect all equipment.We have since found 2 more patients and incidence of melted adapters.

Manufacturer Narrative

No sample/ lot available.However based on the customer stating the product was in use from (b)(6) 2017, our ifu states this product should not be used longer than 30 days as the product can become deformed or discolored.The customer has been provided the ifu and instructed on the proper use of the device.

• Brand Name: CONNECTOR U/ADAPIT STR 22MM ID X 22MM OD
• Type of Device: CONNECTOR, AIRWAY (EXTENSION)
• Manufacturer (Section D): VYAIRE MEDICAL, INC; 26125 n riverwoods blvd; mettawa IL 60045
• Manufacturer (Section G): VYAIRE MEDICAL, INC; cerrada via de la produccion; no. 85., parque industrial mex; mexicali baja california norte ; MX
• Manufacturer Contact: mindy faber ; 26125 n riverwoods blvd; mettawa, IL 60045
• MDR Report Key: 7064131
• MDR Text Key: 93108091
• Report Number: 8030673-2017-00390
• Device Sequence Number: 1
• Product Code: BZA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Respiratory Therapist
• Type of Report: Initial,Followup
• Report Date: 12/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Respiratory Therapist
• Device Catalogue Number: 004081-A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2017
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention