MAUDE Adverse Event Report: VYAIRE MEDICAL SUPERNO2VA SATELLITE KIT MEDIUM; CARDIOPULMONARY RESUSCITATION AID KIT

Model Number SUPERNO2VA SATELLITE KIT MEDIUM

Device Problem Gas/Air Leak (2946)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/12/2020

Event Type  malfunction  

Manufacturer Narrative

At this time, vyaire has not received the suspect device/component for evaluation.Investigation is still ongoing.Therefore, no root cause could be determined yet.Any additional information received from the customer will be included in a follow-up report.

Event Description

The customer reported that the superno2va satellite kit experienced oxygen leak where the green o2 connector meets clear tubing during patient use.The customer confirmed no patient harm.

• Brand Name: SUPERNO2VA SATELLITE KIT MEDIUM
• Type of Device: CARDIOPULMONARY RESUSCITATION AID KIT
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada v[?]a de la producci[?]n; 85 parque undustrial mex iii; mexicali, 21397 ; MX 21397
• Manufacturer Contact: mindy faber ; 26125 n. riverwoods blvd.; mettawa, IL 60045
• MDR Report Key: 9816982
• MDR Text Key: 206393745
• Report Number: 8030673-2020-00090
• Device Sequence Number: 1
• Product Code: OEV
• UDI-Device Identifier: 10190752145443
• UDI-Public: (01)10190752145443
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020281
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SUPERNO2VA SATELLITE KIT MEDIUM
• Device Catalogue Number: SSM-20
• Device Lot Number: 0004106641
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1