MAUDE Adverse Event Report: VENTLAB, LLC VENTLAB; VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)

Model Number AF1140MB

Device Problem Failure to Disconnect (2541)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/15/2018

Event Type  malfunction  

Event Description

We were in the process of intubating a patient when we had the ambu-bag connected to the mask for manual bagging of the pt.Respiratory therapist (rt) went to remove the mask part to connect to the endotracheal tube after it was placed, and the ambu-bag would not disconnect from the mask.She had to put significant force into separating the two pieces when the piece completely broke apart making the ambu-bag useless at this time.We quickly were able to grab another ambu-bag within the room for manual respirations.Zero patient harm occurred.This has occurred in the past and we just want to make sure this goes on record that this has occurred again.

• Brand Name: VENTLAB
• Type of Device: VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
• Manufacturer (Section D): VENTLAB, LLC; 2710 northridge dr nw ste a; grand rapids MI 49544
• MDR Report Key: 8353223
• MDR Text Key: 136598623
• Report Number: 8353223
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AF1140MB
• Device Catalogue Number: AF1140MB
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/18/2019
• Event Location: Hospital
• Date Report to Manufacturer: 02/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 22630 DA
• Patient Weight: 63