MAUDE Adverse Event Report: VENTILAB HIGH FLOW HUMIDIFIER SERIES 6000

Model Number 6000

Device Problems No Audible Alarm (1019); Inaccurate Delivery (2339); Gas/Air Leak (2946)

Patient Problem Hypoxia (1918)

Event Date 05/12/2017

Event Type  Injury  

Event Description

Gas leak with ventilab high flow humidifier at pressure relief without alarm.Less than prescribed oxygen delivery to pt.Oxygen saturation 88% on (b)(6) 2015.High flow oxygen cannula on (b)(6) 2017.Dose or amount: 101, frequency: cont, route: nasal.Dates of use: (b)(6) 2017.Diagnosis or reason for use: hypoxia.Event abated after use stopped or dose stopped: yes.Is the product compounded: no.Is the product over-the-counter: no.

• Brand Name: HIGH FLOW HUMIDIFIER SERIES 6000
• Type of Device: HIGH FLOW HUMIDIFIER SERIES 6000
• Manufacturer (Section D): VENTILAB; mocksville NC 27028
• MDR Report Key: 6568601
• MDR Text Key: 75331513
• Report Number: MW5069781
• Device Sequence Number: 1
• Product Code: BTT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 83 YR
• Patient Weight: 79