MAUDE Adverse Event Report: VYAIRE MEDICAL AIRLIFE; HUMIDIFIER NEBULIZER KIT

Model Number NEB KIT W ADAPTER STERILE WATER 1000 ML

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/11/2019

Event Type  Injury  

Manufacturer Narrative

The sample device is not available for analysis.Additionally, no photo was available.No investigation can be performed and the defect could not be confirmed.Therefore, root cause of failure could not be determined.

Event Description

The customer reported that during use on patient their nebulizer kit's mists works fine initially but when they turn off the flow and restarted it again it does not work anymore.No patient harm was reported.

• Brand Name: AIRLIFE
• Type of Device: HUMIDIFIER NEBULIZER KIT
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada via de la produccilon; 85 industrial mexicali; mexicali, 21397 ; MX 21397
• Manufacturer Contact: stanley tan ; 22745 savi ranch pkwy; yorba linda, CA 92887 ; 7149193324
• MDR Report Key: 9578747
• MDR Text Key: 188822761
• Report Number: 8030673-2020-00067
• Device Sequence Number: 1
• Product Code: CCK
• UDI-Device Identifier: 10885403199141
• UDI-Public: (01)10885403199141(11)20190820(10)0004110253
• 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: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEB KIT W ADAPTER STERILE WATER 1000 ML
• Device Catalogue Number: CK0010
• Device Lot Number: 4110253
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/16/2019
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other