MAUDE Adverse Event Report: VYAIRE MEDICAL AIRLIFE AUTOFILL HUMIDIFICATION CHAMBER; AIRLIFE¿ AUTOFILL HUMIDIFICATION CHAMBER

Catalog Number AH290

Device Problem Premature Separation (4045)

Patient Problem Hypoxia (1918)

Event Date 06/22/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).At this time, vyaire has not received the suspect device/component for evaluation.If additional information becomes available, it will be submitted in a follow up report.

Event Description

Customer reported: the metal bottom of the humidification chamber separated from the plastic top while on patient.Sales reported via email on (b)(6) 2018 that there was no harm to the patient.The end-user was alerted to the failure when the patient's low saturation alarm went off.No sample will be available.

Manufacturer Narrative

Corrected manufacturer site from the initial report# 3003799815-2018-00001.

• Brand Name: AIRLIFE AUTOFILL HUMIDIFICATION CHAMBER
• Type of Device: AIRLIFE¿ AUTOFILL HUMIDIFICATION CHAMBER
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 north riverwoods blvd; mettawa IL 60045
• MDR Report Key: 7723401
• MDR Text Key: 115135066
• Report Number: 3003799815-2018-00001
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 06/25/2018

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: Health Professional
• Device Catalogue Number: AH290
• Device Lot Number: 0004034069
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/28/2018
• Initial Date FDA Received: 07/26/2018
• Supplement Dates Manufacturer Received: 07/26/2018
• Supplement Dates FDA Received: 10/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other