MAUDE Adverse Event Report: SUNMED AP, LTD. VENTLAB BUBBLE HUMIDIFIER; HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)

Model Number 6900

Device Problems Obstruction of Flow (2423); Detachment of Device or Device Component (2907); Device Fell (4014)

Patient Problem Insufficient Information (4580)

Event Date 06/04/2021

Event Type  Injury  

Event Description

Plastic part to the top of the humidifier chamber falls off into the humidifier chamber, occluding oxygen flow to the patient.Fda safety report id# (b)(4).

• Brand Name: VENTLAB BUBBLE HUMIDIFIER
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): SUNMED AP, LTD.; cn
• MDR Report Key: 11974705
• MDR Text Key: 255643467
• Report Number: MW5101789
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 06/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6900
• Device Catalogue Number: 6900
• Device Lot Number: 201000380
• Was Device Available for Evaluation?: 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): Life Threatening