MAUDE Adverse Event Report: VYAIRE MEDICAL CAP NEBULIZER 24 PACK; NEBULIZER (DIRECT PATIENT INTERFACE)

Model Number CAP NEBULIZER 24 PACK

Device Problem Infusion or Flow Problem (2964)

Patient Problem Occlusion (1984)

Event Date 12/17/2019

Event Type  Injury  

Manufacturer Narrative

The sample device is not available for analysis.Therefore, no investigation can be performed.The device history record was reviewed by vyaire and there was no issues found.

Event Description

The customer reported that the patient's aerosol humidifier of cc10 cap nebulizer 24 pack has stopped producing mist even though the bottle had water in it and the flow was adequate.Patient stopped receiving humidity resulting in mucus plugging.Emergency tracheostomy change was done and the equipment was removed from the patient.Patient harm is not known at this time.

• Brand Name: CAP NEBULIZER 24 PACK
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• 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 produccion; 85 industrial mexicali; mexicali, 21397 ; MX 21397
• Manufacturer Contact: stanley tan ; 22745 savi ranch pkwy; yorba linda, CA 92887 ; 7149193324
• MDR Report Key: 9575549
• MDR Text Key: 188823093
• Report Number: 8030673-2020-00065
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 10885403199141
• UDI-Public: (01)10885403199141(10)0004070896
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072119
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/17/2019

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: CAP NEBULIZER 24 PACK
• Device Catalogue Number: CC10
• Device Lot Number: 0004070896
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/17/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention